FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CLINICAL BLOOD GAS
K Number: K935311
·
Decision Dec 22, 1993
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
31
Applicant Total
3
Review Days
50
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Basic Information
- Device Name
- CLINICAL BLOOD GAS
- K Number
- K935311
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.6400
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Acetylene Gas Co.
- Date Received
- November 2, 1993
- Decision Date
- December 22, 1993
- Product Code
- BXK
- 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 |
|---|---|---|---|
| BXK | Gas, Calibration (Specified Concentration) | FDA class 1 | Anesthesiology |
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