The following data is part of a premarket notification filed by Srs Medical Systems, Inc. with the FDA for Srs Vaginal Emg/stimulation Perineometer Sensor Srs Anal Emg/stimulation Perineometer Sensor.
| Device ID | K002834 |
| 510k Number | K002834 |
| Device Name: | SRS VAGINAL EMG/STIMULATION PERINEOMETER SENSOR SRS ANAL EMG/STIMULATION PERINEOMETER SENSOR |
| Classification | Perineometer |
| Applicant | SRS MEDICAL SYSTEMS, INC. 14950 N.E. 95TH ST. Redmond, WA 98052 |
| Contact | Lee Brody |
| Correspondent | Lee Brody SRS MEDICAL SYSTEMS, INC. 14950 N.E. 95TH ST. Redmond, WA 98052 |
| Product Code | HIR |
| CFR Regulation Number | 884.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-12 |
| Decision Date | 2000-11-29 |