FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask
K Number: K233555
·
Decision Jul 31, 2024
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
459
Applicant Total
1
Review Days
268
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Basic Information
- Device Name
- AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask
- K Number
- K233555
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5905
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Philips Respironics
- Date Received
- November 6, 2023
- Decision Date
- July 31, 2024
- 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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