FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IntelliCartTM System
K Number: K190789
·
Decision Apr 24, 2019
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
76
Applicant Total
3
Review Days
28
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Basic Information
- Device Name
- IntelliCartTM System
- K Number
- K190789
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4780
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dornoch Medical Systems
- Date Received
- March 27, 2019
- Decision Date
- April 24, 2019
- Product Code
- JCX
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | FDA class 2 | General, Plastic Surgery |
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