510(k) K130001
K130001 is an FDA 510(k) premarket notification submitted by Foshan Care Medical Technology Co., Ltd. for the device "CARE SU01A SUCTION ASPIRATOR". The FDA issued a decision of Substantially Equivalent on July 25, 2013. The device falls under product code JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered), a Class II device regulated under 21 CFR 878.4780. Foshan Care Medical Technology Co., Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 25, 2013
- Date Received
- January 2, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Apparatus, Suction, Ward Use, Portable, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 878.4780
- Review Panel
- SU
- Submission Type