FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FITMATE SERIES
K Number: K071533
·
Decision Sep 28, 2007
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
32
Applicant Total
10
Review Days
115
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Basic Information
- Device Name
- FITMATE SERIES
- K Number
- K071533
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1730
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cosmed Srl
- Date Received
- June 5, 2007
- Decision Date
- September 28, 2007
- Product Code
- BZL
- 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 |
|---|---|---|---|
| BZL | Computer, Oxygen-Uptake | FDA class 2 | Anesthesiology |
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