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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 K010382
Device Name 100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I
Applicant
Sensidyne, Inc.
16333 Bay Vista Dr.
Clearwater,  FL  33760
Applicant Contact GEORGE MASON
Correspondent
Sensidyne, Inc.
16333 Bay Vista Dr.
Clearwater,  FL  33760
Correspondent Contact GEORGE MASON
Regulation Number868.1720
Classification Product Code
CCL  
Date Received02/08/2001
Decision Date 03/01/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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