The following data is part of a premarket notification filed by Atos Medical Ab with the FDA for Protrach Dualcare.
| Device ID | K151404 |
| 510k Number | K151404 |
| Device Name: | ProTrach Dualcare |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | ATOS MEDICAL AB KRAFTGATAN 8 Horby, SE Se-242 22 |
| Contact | Ferenc Dahner |
| Correspondent | Ferenc Dahner ATOS MEDICAL AB KRAFTGATAN 8 Horby, SE Se-242 22 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-26 |
| Decision Date | 2016-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07331791008351 | K151404 | 000 |
| 07331791015038 | K151404 | 000 |
| 07331791015045 | K151404 | 000 |
| 07331791015052 | K151404 | 000 |
| 07331791015083 | K151404 | 000 |
| 07331791015090 | K151404 | 000 |
| 07331791008184 | K151404 | 000 |
| 07331791008191 | K151404 | 000 |
| 07331791008207 | K151404 | 000 |
| 07331791008214 | K151404 | 000 |
| 07331791008245 | K151404 | 000 |
| 07331791008337 | K151404 | 000 |
| 07331791015021 | K151404 | 000 |