The following data is part of a premarket notification filed by Precision Biometrics, Inc. with the FDA for Myovision 3.0 Wirefree System.
| Device ID | K123399 |
| 510k Number | K123399 |
| Device Name: | MYOVISION 3.0 WIREFREE SYSTEM |
| Classification | Electromyograph, Diagnostic |
| Applicant | PRECISION BIOMETRICS, INC. 2303 W Commodore Way Ste 301 Seattle, WA 98199 |
| Contact | Eric Chen |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IKN |
| Subsequent Product Code | HCC |
| Subsequent Product Code | HCS |
| Subsequent Product Code | KQX |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-11-05 |
| Decision Date | 2013-08-01 |
| Summary: | summary |