The following data is part of a premarket notification filed by Medical Technologies Unlimited, Inc. with the FDA for Comprehensive Neuromuscular Profiler.
| Device ID | K031995 |
| 510k Number | K031995 |
| Device Name: | COMPREHENSIVE NEUROMUSCULAR PROFILER |
| Classification | Electromyograph, Diagnostic |
| Applicant | MEDICAL TECHNOLOGIES UNLIMITED, INC. 7538 BEAR CANYON RD. NE Albuquerque, NM 87109 |
| Contact | Angela Morris |
| Correspondent | Angela Morris MEDICAL TECHNOLOGIES UNLIMITED, INC. 7538 BEAR CANYON RD. NE Albuquerque, NM 87109 |
| Product Code | IKN |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-27 |
| Decision Date | 2004-01-07 |
| Summary: | summary |