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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
510(k) Number K101983
Device Name CRITICAL CARE ASSESSMENT
Applicant
CRITICAL PATIENT CARE, INC.
4005 BLACKHAWK STREET
ENDINBURG,  TX  78539
Applicant Contact MARIE COSGROVE
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact PAULA WILKERSON
Regulation Number870.2780
Classification Product Code
JOM  
Date Received07/14/2010
Decision Date 09/21/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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