FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMOMETRIX CONTINUOUS BLOOD GAS MONITORING SYSTEM
K Number: K920061
·
Decision Mar 30, 1992
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
9
Applicant Total
883
Review Days
83
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Basic Information
- Device Name
- HEMOMETRIX CONTINUOUS BLOOD GAS MONITORING SYSTEM
- K Number
- K920061
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1170
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Abbott Laboratories
- Date Received
- January 7, 1992
- Decision Date
- March 30, 1992
- Product Code
- CBZ
- 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 |
|---|---|---|---|
| CBZ | Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling | FDA class 2 | Anesthesiology |
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