FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AF541 EE Full Face Mask
K Number: K150639
·
Decision Sep 18, 2015
Classifications
1
FEI Numbers
109
Registration Numbers
109
Same Product Code
449
Applicant Total
153
Review Days
191
Basic Information
- Device Name
- AF541 EE Full Face Mask
- K Number
- K150639
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 868.5905
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- RESPIRONICS, INC.
- Date Received
- March 11, 2015
- Decision Date
- September 18, 2015
- 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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