FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
BREAS ISLEEP 20I
K Number: K063476
·
Decision Jan 22, 2007
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
459
Applicant Total
15
Review Days
67
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BREAS ISLEEP 20I
- K Number
- K063476
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.5905
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Breas Medical AB
- Date Received
- November 16, 2006
- Decision Date
- January 22, 2007
- Product Code
- BZD
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BZD), ordered by most recent decision date.
Orion
FDA 510(k)
FDA Class 2
·Anesthesiology
ResScan Essentials
FDA 510(k)
FDA Class 2
·Anesthesiology
Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask
FDA 510(k)
FDA Class 2
·Anesthesiology
F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)
FDA 510(k)
FDA Class 2
·Anesthesiology
MySleepDash
FDA 510(k)
FDA Class 2
·Anesthesiology
Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Breas Medical AB
| K Number | Device Name | ||
|---|---|---|---|
| K242485 | EveryWare | May 20, 2025 | Substantially Equivalent |
| K242438 | Clearo | May 16, 2025 | Substantially Equivalent |
| K233452 | Vivo 45 LS | Jan 13, 2025 | Substantially Equivalent |
| K240779 | Vivo 3 | Dec 13, 2024 | Substantially Equivalent |
| K240778 | Vivo 1, Vivo 2 | Dec 13, 2024 | Substantially Equivalent |
| K193586 | Vivo 45 LS | Jan 27, 2021 | Substantially Equivalent |
| K160481 | Vivo 60 | Nov 9, 2016 | Substantially Equivalent |
| K090113 | BREAS VIVO 40 SYSTEM | May 14, 2009 | Substantially Equivalent |
| K071702 | BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 40 | Feb 15, 2008 | Substantially Equivalent |
| K060657 | ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20. | Aug 18, 2006 | Substantially Equivalent |