FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
2 MICRON AIR ELIMINATING FILTER
K Number: K942532
·
Decision Aug 17, 1994
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
97
Applicant Total
4
Review Days
82
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Basic Information
- Device Name
- 2 MICRON AIR ELIMINATING FILTER
- K Number
- K942532
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medi-Dose, Inc.
- Date Received
- May 27, 1994
- Decision Date
- August 17, 1994
- Product Code
- FPB
- 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 |
|---|---|---|---|
| FPB | Filter, Infusion Line | FDA class 2 | General Hospital |
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