Submission Details
| 510(k) Number | K920260 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 21, 1992 |
| Decision Date | October 13, 1992 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
K920260 is an FDA 510(k) clearance for the INTELECT 600MP, a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II — Special Controls, product code GZJ), submitted by Chattanooga Group, Inc. (Hixson, US). The FDA issued a Cleared decision on October 13, 1992, 266 days after receiving the submission on January 21, 1992. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.
| 510(k) Number | K920260 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 21, 1992 |
| Decision Date | October 13, 1992 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | GZJ — Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 882.5890 |