Calculate FDA 510k Cost [Cost calculated per 510k File] Please enable JavaScript in your browser to complete this form. - Step 1 of 2Layout510k APPLICANT TYPE *ManufacturerSpecification DeveloperManufacturing outsourced is usually refers to specification developer.DEVICE TYPE *Non-Active DeviceSoftware DeviceSoftware Integrated with AIActive DeviceActive Device with SoftwareIn-Vitro Diagnostic DeviceIVD with SoftwareImplantsAnimal Origin DeviceDrug Device CombinationActive Device are devices functions on power Software Devices are SAMD or SIMDPREDICATE DEVICE KNOW? *YESNOPlease make sure you have a predicate device, if not 510k submission not possible.DEVICE FDA CODESinge FDA CodeONE subsequent FDA CodeTWO subsequent FDA CodeTHREE subsequent FDA CodeDatabase research link: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfmNUMBER OF MODELS Models: 0 NUMBER OF VARIANTS Variants: 0 ACCESSORIES SOLD WITH DEVICE Accessories: 0 Accessories are detachable parts of the device which are required for the functioning of the deviceSCOPE OF I3CGLOBAL? *510K Preparation510(K) Preparation + FDA Submission510(K) Preparation + Submission + Coordination510(K) Preparation + Submission + Coordination + US AgentFY 2024, 510k REVIEW FEERegularSmall Business: < $100 million salesThis fee to be paid directly to FDA before file submission. Fee applicable until Sep 2024.Total Summary Name Total ($) 510K APPLICANT TYPE Manufacturer Specification Developer ManufacturerSpecification DeveloperDEVICE TYPE Software Software Integrated with AI Non-Active Device Active Device Active Device with Software In-Vitro Diagnostic Device IVD with Software Implants Animal Orgin Devices Drug Device Combination Software Software Integrated with AINon-Active DeviceActive Device Active Device with SoftwareIn-Vitro Diagnostic DeviceIVD with SoftwareImplantsAnimal Orgin DevicesDrug Device CombinationPREDICATE DEVICE KNOW? YES NO YESNODEVICE FDA CODE Singe FDA Code ONE subsequent FDA Code TWO subsequent FDA Code THREE subsequent FDA Code Singe FDA CodeONE subsequent FDA CodeTWO subsequent FDA CodeTHREE subsequent FDA CodeNUMBER OF MODELS 0 Model 1 Model 2 Models 3 Models 4 Models 5 Models 0 Model1 Model2 Models3 Models4 Models5 ModelsNUMBER OF VARIANTS 0 Variants 1 Variants 2 Variants 3 Variants 4 Variants 5 Variants 6 Variants 7 Variants 8 Variants 9 Variants 10 Variants 11 Variants 12 Variants 13 Variants 14 Variants 15 Variants 16 Variants 17 Variants 18 Variants 19 Variants 20 Variants 21 Variants 22 Variants 23 Variants 24 Variants 25 Variants 26 Variants 27 Variants 28 Variants 29 Variants 30 Variants 31 Variants 32 Variants 33 Variants 34 Variants 35 Variants 36 Variants 37 Variants 38 Variants 39 Variants 40 Variants 41 Variants 42 Variants 43 Variants 44 Variants 45 Variants 46 Variants 47 Variants 48 Variants 49 Variants 50 Variants 0 Variants1 Variants2 Variants3 Variants4 Variants5 Variants6 Variants7 Variants8 Variants9 Variants10 Variants11 Variants12 Variants13 Variants14 Variants15 Variants16 Variants17 Variants18 Variants19 Variants20 VariantsACCESSORIES SOLD WITH DEVICE 0 Accessories 1 Accessories 2 Accessories 3 Accessories 4 Accessories 5 Accessories 6 Accessories 7 Accessories 8 Accessories 9 Accessories 10 Accessories 0 Accessories1 Accessories2 Accessories3 Accessories4 Accessories5 Accessories6 Accessories7 Accessories8 Accessories9 Accessories10 AccessoriesSCOPE OF I3CGLOBAL? 510K Preparation 510(K) Preparation + FDA Submission 510(K) Preparation + Submission + Coordination 510(K) Preparation + Submission + Coordination + US Agent 510K Preparation 510(K) Preparation + FDA Submission 510(K) Preparation + Submission + FDA Coordination510(K) Preparation + Submission + FDA Coordination + US AgentFY 2024, 510K REVIEW FEE Regular Small Business: < $100 million sales RegularSmall Business: < $100 million salesTotal ($) TotalNextLayoutMy Name *My Email *PhonePreviousSend Email
