The following data is part of a premarket notification filed by Biomedical Life Systems, Inc. with the FDA for Galvanic Generator Model Imf4150/a.
| Device ID | K932916 |
| 510k Number | K932916 |
| Device Name: | GALVANIC GENERATOR MODEL IMF4150/A |
| Classification | Stimulator, Muscle, Powered |
| Applicant | BIOMEDICAL LIFE SYSTEMS, INC. 1120 SYCAMORE AVE., STE F P.O. BOX 1360 Vista, CA 92083 |
| Contact | Richard Saxon |
| Correspondent | Richard Saxon BIOMEDICAL LIFE SYSTEMS, INC. 1120 SYCAMORE AVE., STE F P.O. BOX 1360 Vista, CA 92083 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-16 |
| Decision Date | 1994-01-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857771003194 | K932916 | 000 |