FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
AirFit F20
K Number: K153563
·
Decision May 13, 2016
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
459
Applicant Total
103
Review Days
151
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Basic Information
- Device Name
- AirFit F20
- K Number
- K153563
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5905
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Resmed, Ltd.
- Date Received
- December 14, 2015
- Decision Date
- May 13, 2016
- 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 |
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|---|---|---|---|
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