FDA 510k Report

Total Product Life Cycle 510k report 

What is inside the report?

Device Details

Product Details

Device Regulat
on Details

All Manufactures
and Submission

FDA decision
letter (510k, PMA)

Click here for sample report

Check your device class, regulation and
510k requirement

Don’t know the product code
 

 510k Phases

  • 1

    Know your product code

    Here is the product code list

    BRW, BRX etc.

  • 2

    Check your device is required 510k submission or 510k exempt

  • 3

    Get the 510k Total Product Life Cycle Report within 48 hours

    (Review FDA decision letter and substantial device)

  • 4

    Prepare 510k submission

  • 5

    Submit 510k to FDA

Difficulty to decide your product code

Please contact us

medicaldevice510k@gmail.com