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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
510(k) Number K093525
Device Name ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT STATCHECK RESUSCITATOR WITH ACE/STATCHE
Applicant
VENTLAB CORP.
155 BOYCE DRIVE
MOCKSVILLE,  NC  27028
Applicant Contact JAMES A COCHIE
Correspondent
VENTLAB CORP.
155 BOYCE DRIVE
MOCKSVILLE,  NC  27028
Correspondent Contact JAMES A COCHIE
Regulation Number868.1400
Classification Product Code
CCK  
Date Received11/16/2009
Decision Date 12/10/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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