The following data is part of a premarket notification filed by Atos Medical Ab with the FDA for Provox Freehands Flexivoice.
| Device ID | K141380 |
| 510k Number | K141380 |
| Device Name: | PROVOX FREEHANDS FLEXIVOICE |
| Classification | Prosthesis, Laryngeal (taub) |
| Applicant | ATOS MEDICAL AB KRAFTGATAN 8 Horby, SE Se-24222 |
| Contact | Ferenc Dahner |
| Correspondent | Ferenc Dahner ATOS MEDICAL AB KRAFTGATAN 8 Horby, SE Se-24222 |
| Product Code | EWL |
| CFR Regulation Number | 874.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-27 |
| Decision Date | 2014-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07331791010668 | K141380 | 000 |
| 07331791008276 | K141380 | 000 |
| 07331791008283 | K141380 | 000 |
| 07331791008290 | K141380 | 000 |
| 07331791008306 | K141380 | 000 |
| 07331791008313 | K141380 | 000 |
| 07331791008368 | K141380 | 000 |
| 07331791008375 | K141380 | 000 |
| 07331791008382 | K141380 | 000 |
| 07331791008399 | K141380 | 000 |
| 07331791010408 | K141380 | 000 |
| 07331791015175 | K141380 | 000 |