The following data is part of a premarket notification filed by Datex Medical Instrumentation, Inc. with the FDA for As/3 Nmt Module.
| Device ID | K955026 |
| 510k Number | K955026 |
| Device Name: | AS/3 NMT MODULE |
| Classification | Stimulator, Nerve, Peripheral, Electric |
| Applicant | DATEX MEDICAL INSTRUMENTATION, INC. 2 HIGHWOOD DR. Tewksbury, MA 01876 |
| Contact | Joel Kent |
| Correspondent | Joel Kent DATEX MEDICAL INSTRUMENTATION, INC. 2 HIGHWOOD DR. Tewksbury, MA 01876 |
| Product Code | KOI |
| CFR Regulation Number | 868.2775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-02 |
| Decision Date | 1997-04-28 |
| Summary: | summary |