FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
1.2 MICRON AIR ELIMINATING FILTER
K Number: K942625
·
Decision Oct 7, 1994
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
97
Applicant Total
10
Review Days
127
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Basic Information
- Device Name
- 1.2 MICRON AIR ELIMINATING FILTER
- K Number
- K942625
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- The Medi-Dose Group
- Date Received
- June 2, 1994
- Decision Date
- October 7, 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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Other Clearances by The Medi-Dose Group
| K Number | Device Name | ||
|---|---|---|---|
| K952242 | TRANSFEER SPIKE II | Sep 15, 1995 | Substantially Equivalent |
| K900651 | TS-1800 MEDICATION TRANSFER SPIKE | May 7, 1990 | Substantially Equivalent |
| K895291 | IV DISPESNSING SPIKE | Dec 27, 1989 | Substantially Equivalent |
| K895290 | CHEMO-SPIKE RECONSTITUTION DEVICE | Dec 27, 1989 | Substantially Equivalent |
| K896291 | INJECTION PORT II --- FOR INTERMITTENT INJECTION | Dec 1, 1989 | Substantially Equivalent |
| K895419 | DISPOSABLE DISC FILTER | Nov 24, 1989 | Substantially Equivalent |
| K892429 | INJECTION PORT FOR---INTERMITTENT INJECTION | Jul 25, 1989 | Substantially Equivalent |
| K892430 | DISPOSABLE DISC FILTER | Jul 14, 1989 | Substantially Equivalent |
| K892428 | COMBI-CAP | Jul 14, 1989 | Substantially Equivalent |