The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Stimuplex-dig-rc Nerve Stimulator.
| Device ID | K021033 |
| 510k Number | K021033 |
| Device Name: | STIMUPLEX-DIG-RC NERVE STIMULATOR |
| Classification | Stimulator, Nerve, Battery-powered |
| Applicant | B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
| Product Code | BXN |
| CFR Regulation Number | 868.2775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-29 |
| Decision Date | 2003-03-21 |
| Summary: | summary |