K021033 is an FDA 510(k) clearance for the STIMUPLEX-DIG-RC NERVE STIMULATOR. This device is classified as a Stimulator, Nerve, Battery-powered (Class II - Special Controls, product code BXN).
Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on March 21, 2003, 357 days after receiving the submission on March 29, 2002.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2775.
| 510(k) Number | K021033 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 29, 2002 |
| Decision Date | March 21, 2003 |
| Days to Decision | 357 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BXN — Stimulator, Nerve, Battery-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2775 |