The following data is part of a premarket notification filed by Farrall Instruments, Inc. with the FDA for Pp-100, Personal Perineometer.
| Device ID | K821664 |
| 510k Number | K821664 |
| Device Name: | PP-100, PERSONAL PERINEOMETER |
| Classification | Perineometer |
| Applicant | FARRALL INSTRUMENTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HIR |
| CFR Regulation Number | 884.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-28 |
| Decision Date | 1982-07-13 |