The following data is part of a premarket notification filed by Atos Medical Ab with the FDA for Provox Freehands Hme, Model 7710.
| Device ID | K022125 |
| 510k Number | K022125 |
| Device Name: | PROVOX FREEHANDS HME, MODEL 7710 |
| Classification | Prosthesis, Laryngeal (taub) |
| Applicant | ATOS MEDICAL AB KRAFTGATAN 8 P.O.BOX 183 Horby, SE Se-242 22 |
| Contact | Eddy Aberg |
| Correspondent | Eddy Aberg ATOS MEDICAL AB KRAFTGATAN 8 P.O.BOX 183 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 | 2002-07-01 |
| Decision Date | 2002-07-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07331791005022 | K022125 | 000 |
| 07331791002892 | K022125 | 000 |
| 07331791002915 | K022125 | 000 |
| 07331791002922 | K022125 | 000 |
| 07331791002939 | K022125 | 000 |
| 07331791002946 | K022125 | 000 |
| 07331791002953 | K022125 | 000 |
| 07331791002960 | K022125 | 000 |
| 07331791002977 | K022125 | 000 |
| 07331791002991 | K022125 | 000 |
| 07331791003004 | K022125 | 000 |
| 07331791002885 | K022125 | 000 |