510(k) K091408

DISPOSABLE PRESSURE TRANSDUCER by Shenzhen Ant Hi-Tech Industrial Co., Ltd. — Product Code DRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2009
Date Received
May 12, 2009
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