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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 K180902
Device Name MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly
MediPines Corporation
155 N Riverview Drive
Anaheim,  CA  92808
Applicant Contact Steve Lee
MediPines Corporation
155 N. Riverview Drive
Anaheim Hill,  CA  92808
Correspondent Contact Timothy Marcum
Regulation Number868.1400
Classification Product Code
Subsequent Product Codes
Date Received04/06/2018
Decision Date 01/11/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No