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510(k) K070201

BARD INTRA-ABDOMINAL PRESSURE MONITORING DEVICE, MODEL IAP-001 by C.R. Bard, Inc. — Product Code PHU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2007
Date Received
January 22, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intra-Abdominal Pressure Monitoring Device
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Abdominal intracompartmental pressure monitoring using bladder pressure as a surrogate for abdominal pressure.

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