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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
Applicant
Galemed Corp.
29201 Via Norte
Temecula,  CA  92591
Applicant Contact TOM SHANKS
Correspondent
Galemed Corp.
29201 Via Norte
Temecula,  CA  92591
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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