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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 K890144
Device Name OXITRON OXYGEN SENSOR
Applicant
Oxitron Medical Products
8967 Oso Ave.
Unit C
Chatsworth,  CA  91311
Applicant Contact AL CLARK
Correspondent
Oxitron Medical Products
8967 Oso Ave.
Unit C
Chatsworth,  CA  91311
Correspondent Contact AL CLARK
Regulation Number868.1720
Classification Product Code
CCL  
Date Received01/13/1989
Decision Date 05/25/1989
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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