FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LUNG DIFFUSION GAS MIXTURE
K Number: K882817
·
Decision Aug 15, 1988
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
2
Applicant Total
3
Review Days
38
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Basic Information
- Device Name
- LUNG DIFFUSION GAS MIXTURE
- K Number
- K882817
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5710
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Swisco, Inc.
- Date Received
- July 8, 1988
- Decision Date
- August 15, 1988
- Product Code
- BYK
- 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 |
|---|---|---|---|
| BYK | Tent, Oxygen, Electrically Powered | FDA class 2 | Anesthesiology |
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