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510(k) K070710

ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM by Biosensors International-USA — Product Code DRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2007
Date Received
March 14, 2007
Clearance Type
Special
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

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