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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 K920066
Device Name PALCO LABS MODEL 340 PULSE OXIMETER
Applicant
PALCO LABORATORIES, INC.
8030 SOQUEL AVE.
SANTA CRUZ,  CA  95062
Applicant Contact PAUL LEVIN
Correspondent
PALCO LABORATORIES, INC.
8030 SOQUEL AVE.
SANTA CRUZ,  CA  95062
Correspondent Contact PAUL LEVIN
Regulation Number870.2700
Classification Product Code
DQA  
Date Received01/07/1992
Decision Date 03/16/1993
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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