The following data is part of a premarket notification filed by Biomedical Life Systems, Inc. with the FDA for Bmls16-1.
| Device ID | K172971 |
| 510k Number | K172971 |
| Device Name: | BMLS16-1 |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| 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 | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-26 |
| Decision Date | 2018-07-08 |