510(k) K132308

CLIQ DV-300 ASPIRATOR by Ding Hwa Co., Ltd. — Product Code JCX

K132308 is an FDA 510(k) premarket notification submitted by Ding Hwa Co., Ltd. for the device "CLIQ DV-300 ASPIRATOR". The FDA issued a decision of Substantially Equivalent on December 30, 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. Ding Hwa Co., Ltd. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 2013
Date Received
July 25, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Ward Use, Portable, Ac-Powered
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type