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 |