FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPTEX BLOOD GAS MONITORING SYSTEM
K Number: K896311
·
Decision Jan 3, 1990
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
22
Applicant Total
1
Review Days
63
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Basic Information
- Device Name
- OPTEX BLOOD GAS MONITORING SYSTEM
- K Number
- K896311
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1200
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Optex Biomedical
- Date Received
- November 1, 1989
- Decision Date
- January 3, 1990
- Product Code
- CCE
- Advisory Committee
- Anesthesiology
- 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 |
|---|---|---|---|
| CCE | Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling | FDA class 2 | Anesthesiology |
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