FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZAN LUNG-FUNCTION LAB
K Number: K052328
·
Decision Dec 22, 2005
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
89
Applicant Total
2
Review Days
119
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Basic Information
- Device Name
- ZAN LUNG-FUNCTION LAB
- K Number
- K052328
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1880
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zan Messgerate GmbH
- Date Received
- August 25, 2005
- Decision Date
- December 22, 2005
- 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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