510(k) K140809

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

K140809 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 June 23, 2014. 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
June 23, 2014
Date Received
April 1, 2014
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