FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BREATHE NIOV VENTILATION SYSTEM
K Number: K131562
·
Decision Mar 6, 2014
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
5
Applicant Total
3
Review Days
280
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Basic Information
- Device Name
- BREATHE NIOV VENTILATION SYSTEM
- K Number
- K131562
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5895
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Breathe Technologies
- Date Received
- May 30, 2013
- Decision Date
- March 6, 2014
- Product Code
- ONZ
- 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 |
|---|---|---|---|
| ONZ | Mechanical Ventilator | FDA class 2 | Anesthesiology |
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