FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MED-TECH LUNG DIFFUSION MIXTURE
K Number: K953934
·
Decision Sep 18, 1995
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
31
Applicant Total
3
Review Days
31
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Basic Information
- Device Name
- MED-TECH LUNG DIFFUSION MIXTURE
- K Number
- K953934
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.6400
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medical Technical Gases Inc..
- Date Received
- August 18, 1995
- Decision Date
- September 18, 1995
- 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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