FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
Vivo 45 LS
K Number: K233452
·
Decision Jan 13, 2025
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
6
Applicant Total
15
Review Days
451
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Basic Information
- Device Name
- Vivo 45 LS
- K Number
- K233452
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5895
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Breas Medical AB
- Date Received
- October 20, 2023
- Decision Date
- January 13, 2025
- Product Code
- NOU
- 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 |
|---|---|---|---|
| NOU | Continuous, Ventilator, Home Use | FDA class 2 | Anesthesiology |
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Other Clearances by Breas Medical AB
| K Number | Device Name | ||
|---|---|---|---|
| K242485 | EveryWare | May 20, 2025 | Substantially Equivalent |
| K242438 | Clearo | May 16, 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 |
| K063476 | BREAS ISLEEP 20I | Jan 22, 2007 | Substantially Equivalent |
| K060657 | ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20. | Aug 18, 2006 | Substantially Equivalent |