FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NORELCO CLEAN AIR SYSTEM CAS950
K Number: K945161
·
Decision Nov 28, 1994
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
52
Applicant Total
26
Review Days
42
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Basic Information
- Device Name
- NORELCO CLEAN AIR SYSTEM CAS950
- K Number
- K945161
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5045
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hogan & Hartson
- Date Received
- October 17, 1994
- Decision Date
- November 28, 1994
- Product Code
- FRF
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FRF | Cleaner, Air, Medical Recirculating | FDA class 2 | General Hospital |
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