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510(k) K062342

TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT by Sentra Medical Devices, LLC — Product Code DRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2006
Date Received
August 11, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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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