FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OXIMETRIX ACCU SAT CPB
K Number: K811391
·
Decision Jul 20, 1981
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
46
Applicant Total
12
Review Days
63
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Basic Information
- Device Name
- OXIMETRIX ACCU SAT CPB
- K Number
- K811391
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Oximetrix, Inc.
- Date Received
- May 18, 1981
- Decision Date
- July 20, 1981
- Product Code
- DRY
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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| K821056 | FLOW DIRECTED THERMAL-DILUTION CATHETER | May 18, 1982 | Substantially Equivalent |
| K821057 | FLOW DIRECTED THERMAL-DILUTION INFUSION | May 18, 1982 | Substantially Equivalent |
| K820674 | OPTICATH | Mar 25, 1982 | Substantially Equivalent |
| K791868 | OXIMETRIX SHAW HEMOSTATIC SURG. SYS. | Jan 4, 1980 | Substantially Equivalent |
| K781879 | HEATER, OXIMETER SYSTEM | Jan 8, 1979 | Substantially Equivalent |
| K781134 | CATHETER, THERMAL DILUTION FIBEROPTIC | Aug 17, 1978 | Substantially Equivalent |