The following data is part of a premarket notification filed by Medoc Ltd. Advanced Medical Systems with the FDA for Gsa Genito Sensory Analyzer.
| Device ID | K010981 |
| 510k Number | K010981 |
| Device Name: | GSA GENITO SENSORY ANALYZER |
| Classification | Device, Vibration Threshold Measurement |
| Applicant | MEDOC LTD. ADVANCED MEDICAL SYSTEMS 11660 WAYZATA BLVD. Minnetonka, MN 55305 |
| Contact | Ann Quinlan-smith |
| Correspondent | Ann Quinlan-smith MEDOC LTD. ADVANCED MEDICAL SYSTEMS 11660 WAYZATA BLVD. Minnetonka, MN 55305 |
| Product Code | LLN |
| CFR Regulation Number | 882.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-02 |
| Decision Date | 2001-09-20 |