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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 K894350
Device Name SALTER LABS MODEL #4009 SAMPLE LINES
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 Number868.1400
Classification Product Code
CCK  
Date Received07/14/1989
Decision Date 10/03/1989
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
Recalls CDRH Recalls
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