FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEATER, OXIMETER SYSTEM
K Number: K781879
·
Decision Jan 8, 1979
Classifications
1
FEI Numbers
400
Registration Numbers
400
Same Product Code
725
Applicant Total
12
Review Days
63
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Basic Information
- Device Name
- HEATER, OXIMETER SYSTEM
- K Number
- K781879
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Oximetrix, Inc.
- Date Received
- November 6, 1978
- Decision Date
- January 8, 1979
- Product Code
- DQA
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| DQA | Oximeter | FDA class 2 | Cardiovascular |
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Other Clearances by Oximetrix, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K853018 | MODEL 3000 OPTICATH COMPUTER | Jan 13, 1986 | Substantially Equivalent |
| K842622 | HEMO STATIC/ESU SCALPEL SYSTEM | Oct 23, 1984 | Substantially Equivalent |
| K833966 | PUMP INFUSION WEARABLE INFUSION PUMP | Jan 25, 1984 | Substantially Equivalent |
| K823007 | OPTICATH HEPARIN COATED, FLOW-DIRECT | Nov 1, 1982 | Substantially Equivalent |
| 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 |
| K811391 | OXIMETRIX ACCU SAT CPB | Jul 20, 1981 | Substantially Equivalent |
| K791868 | OXIMETRIX SHAW HEMOSTATIC SURG. SYS. | Jan 4, 1980 | Substantially Equivalent |
| K781134 | CATHETER, THERMAL DILUTION FIBEROPTIC | Aug 17, 1978 | Substantially Equivalent |