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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
Recalls CDRH Recalls
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