The following data is part of a premarket notification filed by Atos Medical Ab with the FDA for Provox Micron Hme.
| Device ID | K072582 |
| 510k Number | K072582 |
| Device Name: | PROVOX MICRON HME |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | ATOS MEDICAL AB 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden ATOS MEDICAL AB 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-13 |
| Decision Date | 2008-05-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07331791001567 | K072582 | 000 |
| 07331791001550 | K072582 | 000 |