The following data is part of a premarket notification filed by Breas Medical Ab with the FDA for Breas, Model Ha01.
| Device ID | K060790 |
| 510k Number | K060790 |
| Device Name: | BREAS, MODEL HA01 |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | BREAS MEDICAL AB FORETAGSVAGEN 1 Molnlycke, SE Se 435 33 |
| Contact | Karl-johan Holm |
| Correspondent | Karl-johan Holm BREAS MEDICAL AB FORETAGSVAGEN 1 Molnlycke, SE Se 435 33 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-23 |
| Decision Date | 2006-05-25 |
| Summary: | summary |