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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)
Applicant
SPACELABS HEALTHCARE
P.O. BOX 3018
NEDERLAND,  CO  80466
Applicant Contact THOMAS KROENKE
Correspondent
SPACELABS HEALTHCARE
P.O. BOX 3018
NEDERLAND,  CO  80466
Correspondent Contact THOMAS KROENKE
Regulation Number868.1400
Classification Product Code
CCK  
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
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