The following data is part of a premarket notification filed by Atos Medical Ab with the FDA for Provox(tm) Voice Prosthesis.
| Device ID | K940638 |
| 510k Number | K940638 |
| Device Name: | PROVOX(TM) VOICE PROSTHESIS |
| Classification | Prosthesis, Laryngeal (taub) |
| Applicant | ATOS MEDICAL AB P.O. BOX 183 Horby, Sweden, SE Se-24222 |
| Contact | Karl-erik Karlsson |
| Correspondent | Karl-erik Karlsson ATOS MEDICAL AB P.O. BOX 183 Horby, Sweden, 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 | 1994-02-14 |
| Decision Date | 1994-06-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07331791005961 | K940638 | 000 |
| 07331791005954 | K940638 | 000 |
| 07331791005947 | K940638 | 000 |
| 07331791000867 | K940638 | 000 |
| 07331791000782 | K940638 | 000 |