The following data is part of a premarket notification filed by Biomedical Life Systems, Inc. with the FDA for Electro Neuromuscular Stimulator Model 2000.
| Device ID | K884651 |
| 510k Number | K884651 |
| Device Name: | ELECTRO NEUROMUSCULAR STIMULATOR MODEL 2000 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | BIOMEDICAL LIFE SYSTEMS, INC. 1285 STONE DR. #103 P.O. BOX 128 San Marcos, CA 92069 |
| Contact | Richard G Saxon |
| Correspondent | Richard G Saxon BIOMEDICAL LIFE SYSTEMS, INC. 1285 STONE DR. #103 P.O. BOX 128 San Marcos, CA 92069 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-07 |
| Decision Date | 1989-11-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857771003170 | K884651 | 000 |