FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYSTEM 82 COMPUTERIZED LUNG VO. SPIRO
K Number: K801918
·
Decision Oct 3, 1980
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
89
Applicant Total
3
Review Days
53
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Basic Information
- Device Name
- SYSTEM 82 COMPUTERIZED LUNG VO. SPIRO
- K Number
- K801918
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1880
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Pulmonary Testing Systems
- Date Received
- August 11, 1980
- Decision Date
- October 3, 1980
- 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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