FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
BIONAIRE CLEAR AIR AIR PURIFIER & IONIZER
K Number: K942434
·
Decision Dec 14, 1994
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
52
Applicant Total
2
Review Days
208
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Basic Information
- Device Name
- BIONAIRE CLEAR AIR AIR PURIFIER & IONIZER
- K Number
- K942434
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5045
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bionaire Corp.
- Date Received
- May 20, 1994
- Decision Date
- December 14, 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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Other Clearances by Bionaire Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K942683 | BIONAIRE HEPA AIR PURIFIERS /SH-1240, 1260, 1840, 1860, CH-3550 | Nov 28, 1994 | Substantially Equivalent |