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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, Oxygen, Gaseous-Phase
510(k) Number K880378
Device Name LOTA, LIFECARE OXYGEN/TEMPERATURE ANALYZER 36-001
Applicant
Lifecare Services, Inc.
655 Aspen Ridge Dr.
Lafayette,  CO  80026
Applicant Contact HAROLD ELLERINGTON
Correspondent
Lifecare Services, Inc.
655 Aspen Ridge Dr.
Lafayette,  CO  80026
Correspondent Contact HAROLD ELLERINGTON
Regulation Number868.1720
Classification Product Code
CCL  
Date Received01/27/1988
Decision Date 09/30/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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