US FDA Approval

The US FDA has classified the Medical Devices as

  • Class 1 devices
  • Class 2 devices
  • Class 3 devices

Every classified device has a 3 Alphabet Code assigned by US FDA and from there you can get the classification of your device.


We support our clients in

  1. Facility Registration
  2. Class 1 Device Listing
  3. Class 2 510K Approvals (A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device)
  4. 21CFR820 Compliance
  5. Training on FDA Audits


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