FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER
K Number: K012939
·
Decision Sep 28, 2001
Classifications
1
FEI Numbers
187
Registration Numbers
188
Same Product Code
503
Applicant Total
33
Review Days
28
Basic Information
- Device Name
- AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER
- K Number
- K012939
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.5630
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- MONAGHAN MEDICAL CORP.
- Date Received
- August 31, 2001
- Decision Date
- September 28, 2001
- 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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