K813008 is an FDA 510(k) clearance for the RESPOND II...NEUROMUSCULAR STIMULATOR. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Medtronic Vascular (Walker, US). The FDA issued a Cleared decision on December 2, 1981, 36 days after receiving the submission on October 27, 1981.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K813008 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 27, 1981 |
| Decision Date | December 02, 1981 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IPF — Stimulator, Muscle, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5850 |