The following data is part of a premarket notification filed by Biomedical Life Systems, Inc. with the FDA for Electro Neuromuscular Stimulator, Model Bmls03-1.
| Device ID | K031427 |
| 510k Number | K031427 |
| Device Name: | ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS03-1 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | BIOMEDICAL LIFE SYSTEMS, INC. P.O. BOX 1360 Vista, CA 92085 -1360 |
| Contact | Richard Saxon |
| Correspondent | Richard Saxon BIOMEDICAL LIFE SYSTEMS, INC. P.O. BOX 1360 Vista, CA 92085 -1360 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-06 |
| Decision Date | 2003-08-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857771003200 | K031427 | 000 |