FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AEROLIFE ULTRASONIC NEBULIZER, MODEL P2C
K Number: K053360
·
Decision Mar 23, 2006
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
507
Applicant Total
1
Review Days
111
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Basic Information
- Device Name
- AEROLIFE ULTRASONIC NEBULIZER, MODEL P2C
- K Number
- K053360
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5630
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Aerovectrx Corporation
- Date Received
- December 2, 2005
- Decision Date
- March 23, 2006
- Product Code
- CAF
- 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 |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | FDA class 2 | Anesthesiology |
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