K051635 is an FDA 510(k) clearance for the DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIES. This device is classified as a Stimulator, Nerve, Peripheral, Electric (Class II - Special Controls, product code KOI).
Submitted by Ge Healthcare (Needham, US). The FDA issued a Cleared decision on July 15, 2005, 25 days after receiving the submission on June 20, 2005.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2775.
| 510(k) Number | K051635 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 20, 2005 |
| Decision Date | July 15, 2005 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | KOI — Stimulator, Nerve, Peripheral, Electric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2775 |