The following data is part of a premarket notification filed by Teleemg, Llc Usa with the FDA for Focus Emg Device.
| Device ID | K102610 |
| 510k Number | K102610 |
| Device Name: | FOCUS EMG DEVICE |
| Classification | Electromyograph, Diagnostic |
| Applicant | TELEEMG, LLC USA 65 ARLINGTON ROAD Woburn, MA 01801 |
| Contact | Joe F Jabre, M.d. |
| Correspondent | Joe F Jabre, M.d. TELEEMG, LLC USA 65 ARLINGTON ROAD Woburn, MA 01801 |
| Product Code | IKN |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-10 |
| Decision Date | 2011-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04650075330074 | K102610 | 000 |