The following data is part of a premarket notification filed by Atos Medical Ab with the FDA for Provox Nid Voice Rehabilitation System, Model Ref 7101 To 7134.
| Device ID | K043138 |
| 510k Number | K043138 |
| Device Name: | PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134 |
| Classification | Prosthesis, Laryngeal (taub) |
| Applicant | ATOS MEDICAL AB KRAFTGATAN 8 Horby, SE Se-242 22 |
| Contact | Eddy Aberg |
| Correspondent | Eddy Aberg ATOS MEDICAL AB KRAFTGATAN 8 Horby, SE Se-242 22 |
| Product Code | EWL |
| CFR Regulation Number | 874.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-12 |
| Decision Date | 2004-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07331791000386 | K043138 | 000 |
| 07331791000287 | K043138 | 000 |
| 07331791000294 | K043138 | 000 |
| 07331791000300 | K043138 | 000 |
| 07331791000317 | K043138 | 000 |
| 07331791000324 | K043138 | 000 |
| 07331791000331 | K043138 | 000 |
| 07331791000348 | K043138 | 000 |
| 07331791000355 | K043138 | 000 |
| 07331791000362 | K043138 | 000 |
| 07331791000379 | K043138 | 000 |
| 07331791000270 | K043138 | 000 |