The following data is part of a premarket notification filed by Bio-medical Research, Ltd. with the FDA for Neurotech Baxolve Type 294.
| Device ID | K023913 |
| 510k Number | K023913 |
| Device Name: | NEUROTECH BAXOLVE TYPE 294 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | BIO-MEDICAL RESEARCH, LTD. PARKMORE BUSINESS PARK, West Galway, IE |
| Contact | Michelle Sawyer |
| Correspondent | Michelle Sawyer BIO-MEDICAL RESEARCH, LTD. PARKMORE BUSINESS PARK, West Galway, IE |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-25 |
| Decision Date | 2003-08-25 |
| Summary: | summary |