The following data is part of a premarket notification filed by Teleemg, Llc Usa with the FDA for Neuro-audio.
| Device ID | K141524 |
| 510k Number | K141524 |
| Device Name: | NEURO-AUDIO |
| Classification | Audiometer |
| Applicant | TELEEMG, LLC USA 88 STILES ROAD Salem, NH 03079 |
| Contact | Barry Ashar |
| Correspondent | Barry Ashar TELEEMG, LLC USA 88 STILES ROAD Salem, NH 03079 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-09 |
| Decision Date | 2015-03-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04650075330036 | K141524 | 000 |