FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BAXA EXACTA-MED PHARMACY PUMP
K Number: K873875
·
Decision Nov 24, 1987
Classifications
1
FEI Numbers
149
Registration Numbers
149
Same Product Code
847
Applicant Total
16
Review Days
63
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Basic Information
- Device Name
- BAXA EXACTA-MED PHARMACY PUMP
- K Number
- K873875
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Baxa Corp., Sub. of Cook Group, Inc.
- Date Received
- September 22, 1987
- Decision Date
- November 24, 1987
- Product Code
- FRN
- 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 |
|---|---|---|---|
| FRN | Pump, Infusion | FDA class 2 | General Hospital |
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Other Clearances by Baxa Corp., Sub. of Cook Group, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K910257 | BAXA PCA INFUSOR | Nov 7, 1991 | Substantially Equivalent |
| K903159 | VALVE CONTROLLER FOR MICROMACRO COMPOUNDER | Nov 7, 1990 | Substantially Equivalent |
| K904225 | KWIKMIX | Nov 5, 1990 | Substantially Equivalent |
| K900585 | TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP | Apr 18, 1990 | Substantially Equivalent |
| K872743 | BAXA TUBING SETS (FOR PHARMACY PUMP) | Oct 9, 1987 | Substantially Equivalent |
| K844904 | CYTOSAFE NEEDLE | Feb 22, 1985 | Substantially Equivalent |
| K832332 | VENTED I.V. TRANSFER NEEDLE | Sep 12, 1983 | Substantially Equivalent |
| K832312 | I.V. TRANSFER NEEDLE | Sep 12, 1983 | Substantially Equivalent |
| K832347 | TWOFER NEEDLE | Sep 12, 1983 | Substantially Equivalent |
| K832254 | BAXA ADDISEAL | Jul 26, 1983 | Substantially Equivalent |