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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 K881663
Device Name OXYGEN/TEMPERATURE ANALYZER MODEL 300 SERIES
Applicant
Salter Labs
P.O. Box 608
Arvin,  CA  93203
Applicant Contact JAMES N CURTI
Correspondent
Salter Labs
P.O. Box 608
Arvin,  CA  93203
Correspondent Contact JAMES N CURTI
Regulation Number868.1720
Classification Product Code
CCL  
Date Received04/15/1988
Decision Date 08/19/1988
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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