The following data is part of a premarket notification filed by Murray Electronics with the FDA for Bionicare Stimilator System, Model Bio-1000.
| Device ID | K983228 |
| 510k Number | K983228 |
| Device Name: | BIONICARE STIMILATOR SYSTEM, MODEL BIO-1000 |
| Classification | Stimulator, Electrical, Transcutaneous, For Arthritis |
| Applicant | MURRAY ELECTRONICS 260 SCHILLING CIRCLE Hunt Valley, MD 21031 |
| Contact | Kent C Hoffman |
| Correspondent | Kent C Hoffman MURRAY ELECTRONICS 260 SCHILLING CIRCLE Hunt Valley, MD 21031 |
| Product Code | NYN |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-15 |
| Decision Date | 1999-03-15 |
| Summary: | summary |