510(k) K121587

BREATH SHAKE by Cheen Houng Ent. Co. , Ltd. — Product Code BYI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2013
Date Received
May 31, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Percussor, Powered-Electric
Device Class
Class II
Regulation Number
868.5665
Review Panel
AN
Submission Type