FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AUTOPRIME
K Number: K964283
·
Decision Jan 22, 1997
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
97
Applicant Total
10
Review Days
86
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Basic Information
- Device Name
- AUTOPRIME
- K Number
- K964283
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arbor Technologies, Inc.
- Date Received
- October 28, 1996
- Decision Date
- January 22, 1997
- 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 Arbor Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K960928 | SYRINGEFILTER | Apr 4, 1997 | Substantially Equivalent |
| K922777 | PRESSURE TUBING AND ACCESSORIES | Mar 22, 1994 | Substantially Equivalent |
| K902666 | ANESTHESIA CONDUCTION FILTER | Apr 23, 1991 | Substantially Equivalent |
| K895859 | CONTAIN(TM) | Feb 7, 1991 | Substantially Equivalent |
| K902167 | CONTAIN(TM) LASER PLUME FILTER | Jan 4, 1991 | Substantially Equivalent |
| K890844 | MICROSEPT 60/20 | Jun 7, 1989 | Substantially Equivalent |
| K874505 | CONTAIN(TM) | May 20, 1988 | Substantially Equivalent |
| K864113 | CLYDE (TM) FILTRATION SYSTEM | Feb 4, 1987 | Substantially Equivalent |
| K863162 | VACU-GUARD | Aug 29, 1986 | Substantially Equivalent |