FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LUNG DIFFUSION
K Number: K935309
·
Decision Sep 27, 1994
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
89
Applicant Total
3
Review Days
329
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Basic Information
- Device Name
- LUNG DIFFUSION
- K Number
- K935309
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1880
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Acetylene Gas Co.
- Date Received
- November 2, 1993
- Decision Date
- September 27, 1994
- Product Code
- BZC
- 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 |
|---|---|---|---|
| BZC | Calculator, Pulmonary Function Data | FDA class 2 | Anesthesiology |
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