FDA 510(k)
Substantially Equivalent
🇺🇸 United States
FLOW DIRECTED THERMAL-DILUTION CATHETER
K Number: K821056
·
Decision May 18, 1982
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
12
Review Days
33
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Basic Information
- Device Name
- FLOW DIRECTED THERMAL-DILUTION CATHETER
- K Number
- K821056
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Oximetrix, Inc.
- Date Received
- April 15, 1982
- Decision Date
- May 18, 1982
- Advisory Committee
- Unknown
- Review Advisory Committee
- CV
- Third Party
- N
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|---|---|---|---|
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| K833966 | PUMP INFUSION WEARABLE INFUSION PUMP | Jan 25, 1984 | Substantially Equivalent |
| K823007 | OPTICATH HEPARIN COATED, FLOW-DIRECT | Nov 1, 1982 | Substantially Equivalent |
| K821057 | FLOW DIRECTED THERMAL-DILUTION INFUSION | May 18, 1982 | Substantially Equivalent |
| K820674 | OPTICATH | Mar 25, 1982 | Substantially Equivalent |
| K811391 | OXIMETRIX ACCU SAT CPB | Jul 20, 1981 | 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 |