The following data is part of a premarket notification filed by Breas Medical Ab with the FDA for Isleep By Breas, Models Isleep 10, Isleep 20..
| Device ID | K060657 |
| 510k Number | K060657 |
| Device Name: | ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20. |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | BREAS MEDICAL AB FORETAGSVAGEN 1 Molnlycke, SE 435 33 |
| Contact | Karl-johan Holm |
| Correspondent | Karl-johan Holm BREAS MEDICAL AB FORETAGSVAGEN 1 Molnlycke, SE 435 33 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-13 |
| Decision Date | 2006-08-18 |
| Summary: | summary |