FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
CATSmart
K Number: K160735
·
Decision Sep 16, 2016
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
194
Applicant Total
12
Review Days
183
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Basic Information
- Device Name
- CATSmart
- K Number
- K160735
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5830
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fresenius Kabi AG
- Date Received
- March 17, 2016
- Decision Date
- September 16, 2016
- Product Code
- CAC
- 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 |
|---|---|---|---|
| CAC | Apparatus, Autotransfusion | FDA class 2 | Anesthesiology |
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