FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROSEPT 60/20
K Number: K890844
·
Decision Jun 7, 1989
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
35
Applicant Total
10
Review Days
106
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Basic Information
- Device Name
- MICROSEPT 60/20
- K Number
- K890844
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Arbor Technologies, Inc.
- Date Received
- February 21, 1989
- Decision Date
- June 7, 1989
- Product Code
- CAK
- 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 |
|---|---|---|---|
| CAK | Microfilter, Blood Transfusion | 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 |
| K964283 | AUTOPRIME | Jan 22, 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 |
| 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 |