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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 K002787
Device Name MODEL 120, OXYSOFT, INFRARED DATA CONVERTER, MODEL 120
Applicant
PALCO LABS, INC.
8030 SOQUEL AVE.
SANTA CRUZ,  CA  95062
Applicant Contact RICHELLA GOO
Correspondent
PALCO LABS, INC.
8030 SOQUEL AVE.
SANTA CRUZ,  CA  95062
Correspondent Contact RICHELLA GOO
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/07/2000
Decision Date 11/29/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Special
Reviewed by Third Party No
Combination Product No
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