The following data is part of a premarket notification filed by Atos Medical Ab with the FDA for Provox Hme Cassette, Model 7240; Provox Adhesive, Model 7251.
| Device ID | K014102 |
| 510k Number | K014102 |
| Device Name: | PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251 |
| Classification | Tube Tracheostomy And Tube Cuff |
| 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 | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-13 |
| Decision Date | 2002-02-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07331791001697 | K014102 | 000 |