510(k) K152472

Disposable Pressure Transducer by Zhejiang Haisheng Medical Device Co., Ltd. — Product Code DRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2016
Date Received
August 31, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Blood-Pressure, Extravascular
Device Class
Class II
Regulation Number
870.2850
Review Panel
CV
Submission Type