The following data is part of a premarket notification filed by Uroval with the FDA for Uroval Brs System, Model Brs01; Telesis, Model Promo1.
| Device ID | K083679 |
| 510k Number | K083679 |
| Device Name: | UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1 |
| Classification | Electromyograph, Diagnostic |
| Applicant | UROVAL 5353 WAYZATA BLVD. SUITE 505 Minneapolis, MN 55416 |
| Contact | Sharon Iverson |
| Correspondent | Sharon Iverson UROVAL 5353 WAYZATA BLVD. SUITE 505 Minneapolis, MN 55416 |
| Product Code | IKN |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-11 |
| Decision Date | 2009-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852523007062 | K083679 | 000 |