US FDA 510k and Registration for Gloves
Medical gloves are mainly used to protect the wearer and/or the patient from the spread of infection...
FDA Registration of Wheelchair
Most appropriate code is KNN and it is 510(k) exempted devices. Â Â Â Â Â Â Â Â KNN Â...
Ophthalmic Device FDA Registration
OPHTHALMIC DEVICES ( Non-active Class I devices) Â Ophthalmic devices are designed to preven...
FDA 510k approval for Surgical Drapes
Surgical Drapes are used to cover the parts of the body other than those which needs to be examined ...
Different types of Thermometers, Classification and Conformity assessment and routes for MDR CE Marking
Sl. No. Product Identification MDR Classification and Rule Conformity Assessment Route 1. Cli...
Safety and Performance Based 510(k)
The Safety and Performance Based Pathway is generally preferred for well-understood medical devices ...