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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 K892406
Device Name MODIFIED OXYGEN DELIVERY/CO2 SAMPLE NASAL CANNULA
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 Received04/07/1989
Decision Date 07/24/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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