FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ABL5 BLOOD GAS SYSTEM;BPH5 BLOOD PH SYSTEM
K Number: K943882
·
Decision Mar 10, 1995
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
186
Applicant Total
49
Review Days
213
Basic Information
- Device Name
- ABL5 BLOOD GAS SYSTEM;BPH5 BLOOD PH SYSTEM
- K Number
- K943882
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1120
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- RADIOMETER AMERICA, INC.
- Date Received
- August 9, 1994
- Decision Date
- March 10, 1995
- Product Code
- CHL
- 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 |
|---|---|---|---|
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | FDA class 2 | Clinical Chemistry |
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