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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K904988
Device Name PALCO LABS MODEL 400 OXYGEN/PULSE MONITOR
Applicant
PALCO LABORATORIES, INC.
1595 SOQUEL DR.
SANTA CRUZ,  CA  95065
Applicant Contact PAUL LEVIN
Correspondent
PALCO LABORATORIES, INC.
1595 SOQUEL DR.
SANTA CRUZ,  CA  95065
Correspondent Contact PAUL LEVIN
Regulation Number870.2700
Classification Product Code
DQA  
Date Received11/07/1990
Decision Date 03/18/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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