FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
CARE SU01A SUCTION ASPIRATOR
K Number: K130001
·
Decision Jul 25, 2013
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
76
Applicant Total
4
Review Days
204
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CARE SU01A SUCTION ASPIRATOR
- K Number
- K130001
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4780
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Foshan Care Medical Technology Co., Ltd.
- Date Received
- January 2, 2013
- Decision Date
- July 25, 2013
- Product Code
- JCX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- Y
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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JCX), ordered by most recent decision date.
Protable Phlegm Suction Unit (JMA D01)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MV Flow Aspiration Pump (MVFLOWPMP01)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Cary
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Riptide Aspiration Pump; Riptide Collection Canister with Intermediate Tubing
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Easycess Aspiration Pump
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery