FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LUNG DIFFUSION GAS MIXTURE
K Number: K924796
·
Decision Dec 17, 1992
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
31
Applicant Total
2
Review Days
85
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Basic Information
- Device Name
- LUNG DIFFUSION GAS MIXTURE
- K Number
- K924796
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.6400
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Gulf States Airgas
- Date Received
- September 23, 1992
- Decision Date
- December 17, 1992
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BXK), ordered by most recent decision date.
BLOOD GAS MIXTURES
FDA 510(k)
FDA Class 1
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LUNG DIFFUSION MIXTURES
FDA 510(k)
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LUNG DIFFUSION MIXTURE
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MEDICAL MIXTURE-LUNG DIFFUSION GAS MIXTURES
FDA 510(k)
FDA Class 1
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MED-TECH LUNG DIFFUSION MIXTURE
FDA 510(k)
FDA Class 1
·Anesthesiology
MEDICAL MIXTURE-CLINICAL BLOOD GAS MIXTURES
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Gulf States Airgas
| K Number | Device Name | ||
|---|---|---|---|
| K924795 | BLOOD GAS MIXTURE | Dec 17, 1992 | Substantially Equivalent |