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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name monitor, airway pressure (includes gauge and/or alarm)
510(k) Number K122627
Device Name GIO DIGITAL PRESSURE GUAGES
Original Applicant
GALEMED CORP.
29201 via norte
temecula,  CA  92591
Original Contact tom shanks
Regulation Number868.2600
Classification Product Code
CAP  
Date Received08/28/2012
Decision Date 08/22/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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