FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
CAS-One Liver
K Number: K143024
·
Decision Apr 28, 2015
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
3
Applicant Total
6
Review Days
189
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Basic Information
- Device Name
- CAS-One Liver
- K Number
- K143024
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cascination AG
- Date Received
- October 21, 2014
- Decision Date
- April 28, 2015
- Product Code
- OEW
- Advisory Committee
- Neurology
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| OEW | Tracking, Soft Tissue, Intraoperative | FDA class 2 | Neurology |
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