FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERFORMAX PEDIATRIC SE TOTAL FACE MASK
K Number: K120639
·
Decision Jul 10, 2012
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
504
Applicant Total
172
Review Days
130
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Basic Information
- Device Name
- PERFORMAX PEDIATRIC SE TOTAL FACE MASK
- K Number
- K120639
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5895
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Respironics, Inc.
- Date Received
- March 2, 2012
- Decision Date
- July 10, 2012
- Product Code
- CBK
- 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 |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | FDA class 2 | Anesthesiology |
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