The following data is part of a premarket notification filed by Pirdy, Inc. with the FDA for Pird-y.
| Device ID | K842262 |
| 510k Number | K842262 |
| Device Name: | PIRD-Y |
| Classification | Stimulator, Muscle, Diagnostic |
| Applicant | PIRDY, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | ISB |
| CFR Regulation Number | 890.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-07 |
| Decision Date | 1984-06-28 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PIRD-Y 73558006 1453622 Dead/Cancelled |
YLVISAKER, CARL J. 1985-09-13 |