The following data is part of a premarket notification filed by Breas Medical Ab with the FDA for Breas Isleep 20i.
| Device ID | K063476 |
| 510k Number | K063476 |
| Device Name: | BREAS ISLEEP 20I |
| 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 | 2006-11-16 |
| Decision Date | 2007-01-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07321822070167 | K063476 | 000 |