The following data is part of a premarket notification filed by Biomedical Life Systems, Inc. with the FDA for Model Bmls03-7.
| Device ID | K042711 |
| 510k Number | K042711 |
| Device Name: | MODEL BMLS03-7 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | BIOMEDICAL LIFE SYSTEMS, INC. P.O. BOX 1360 Vista, CA 92085 -1360 |
| Contact | Gary Bussett |
| Correspondent | Gary Bussett BIOMEDICAL LIFE SYSTEMS, INC. P.O. BOX 1360 Vista, CA 92085 -1360 |
| Product Code | GZJ |
| Subsequent Product Code | IPF |
| Subsequent Product Code | LIH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-30 |
| Decision Date | 2005-03-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857771003255 | K042711 | 000 |