FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CLINICAL BLOOD GAS MIXTURES
K Number: K904163
·
Decision Nov 1, 1990
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
8
Applicant Total
3
Review Days
51
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Basic Information
- Device Name
- CLINICAL BLOOD GAS MIXTURES
- K Number
- K904163
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Norco, Inc.
- Date Received
- September 11, 1990
- Decision Date
- November 1, 1990
- Product Code
- LCH
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| LCH | Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical | FDA class 1 | Clinical Chemistry |
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