K042003 is an FDA 510(k) clearance for the INFINITY TRIDENT NMT POD. This device is classified as a Stimulator, Nerve, Peripheral, Electric (Class II - Special Controls, product code KOI).
Submitted by Draeger Medical Systems, Inc. (Danvers, US). The FDA issued a Cleared decision on September 1, 2004, 37 days after receiving the submission on July 26, 2004.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2775.
| 510(k) Number | K042003 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 26, 2004 |
| Decision Date | September 01, 2004 |
| Days to Decision | 37 days |
| Submission Type | Traditional |
| 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 |