K010981 is an FDA 510(k) clearance for the GSA GENITO SENSORY ANALYZER. This device is classified as a Device, Vibration Threshold Measurement (Class I - General Controls, product code LLN).
Submitted by Medoc Ltd. Advanced Medical Systems (Minnetonka, US). The FDA issued a Cleared decision on September 20, 2001, 171 days after receiving the submission on April 2, 2001.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1200.
| 510(k) Number | K010981 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 02, 2001 |
| Decision Date | September 20, 2001 |
| Days to Decision | 171 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | LLN — Device, Vibration Threshold Measurement |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 882.1200 |