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510(k) K110645

BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR by Sonosite,Inc. — Product Code DSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2011
Date Received
March 4, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Plethysmograph, Impedance
Device Class
Class II
Regulation Number
870.2770
Review Panel
CV
Submission Type

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