The following data is part of a premarket notification filed by Bio-research Associates, Inc. with the FDA for Quadratens, Model Qt-42.
| Device ID | K061799 |
| 510k Number | K061799 |
| Device Name: | QUADRATENS, MODEL QT-42 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | BIO-RESEARCH ASSOCIATES, INC. 9275 NORTH 49TH STREET SUITE 150 Brown Deer, WI 53223 |
| Contact | John C Radke |
| Correspondent | John C Radke BIO-RESEARCH ASSOCIATES, INC. 9275 NORTH 49TH STREET SUITE 150 Brown Deer, WI 53223 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-26 |
| Decision Date | 2006-08-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860003499979 | K061799 | 000 |