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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 K121017
Device Name CAPNOGRAPHY PAD (92516)
Original Applicant
p.o. box 3018
nederland,  CO  80466
Original Contact thomas kroenke
Regulation Number868.1400
Classification Product Code
Date Received04/04/2012
Decision Date 07/13/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No