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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 K943842
Device Name PULSE OXIMETER MODEL 305
Applicant
PALCO LABORATORIES, INC.
8030 SOQUEL AVE.
SANTA CRUZ,  CA  95062
Applicant Contact PAUL D LEVIN
Correspondent
PALCO LABORATORIES, INC.
8030 SOQUEL AVE.
SANTA CRUZ,  CA  95062
Correspondent Contact PAUL D LEVIN
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/05/1994
Decision Date 03/24/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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