FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ABRACAIR AIR CLEANER, MODEL QTZ300-60; ABRACAIR AIR CLEANER, MODEL TI 100-30P
K Number: K052732
·
Decision Feb 24, 2006
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
35
Applicant Total
1
Review Days
148
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Basic Information
- Device Name
- ABRACAIR AIR CLEANER, MODEL QTZ300-60; ABRACAIR AIR CLEANER, MODEL TI 100-30P
- K Number
- K052732
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6500
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abracair, Inc.
- Date Received
- September 29, 2005
- Decision Date
- February 24, 2006
- Product Code
- FRA
- 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 |
|---|---|---|---|
| FRA | Purifier, Air, Ultraviolet, Medical | FDA class 2 | General Hospital |
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