Breas Isleep 20I
FDA 510(k) K063476 · Breas Medical AB
510(k) numberK063476
Submission
- Device name
- Breas Isleep 20I
- Applicant
- Breas Medical AB
Molnlycke, SE - Received
- November 16, 2006
- Decision date
- January 22, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZD – Ventilator, Non-Continuous (Respirator)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5905
- Specialty
- Anesthesiology
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| K251847 | Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskBZD · Traditional | Sleepnet Corporation | 01/15/2026SE |
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| K251770 | SleepRes PAP SystemBZD · Traditional | Sleepres, Inc. | 12/15/2025SE |
| K251657 | Personalized Therapy Comfort Settings (PTCS)BZD · Traditional | Resmed Corp | 12/05/2025SE |
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| K090113 | Breas Vivo 40 SystemMNT · Traditional | 05/14/2009SE |
| K071702 | Breas Vivo Bilevel System, Model Vivo 40MNT · Traditional | 02/15/2008SE |
| K060657 | Isleep by Breas, Models Isleep 10, Isleep 20.BZD · Special | 08/18/2006SE |
Questions and answers
When was Breas Isleep 20I cleared by the FDA?
Breas Isleep 20I (K063476) received a 510(k) decision of Substantially Equivalent on January 22, 2007, 67 days after the submission was received.
What is the product code of K063476?
The FDA product code is BZD – Ventilator, Non-Continuous (Respirator), a Class II (moderate risk) device regulated under 21 CFR 868.5905.