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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, digoxin (125-i), goat antibody, anion exchange, resin sep.
510(k) Number K032291
Device Name TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM
Applicant
LINDE MEDICAL SENSORS AG
AUSTRASSE 25
BASEL,  CH CH-4051
Applicant Contact JEAN-PIERRE PALMA
Correspondent
LINDE MEDICAL SENSORS AG
AUSTRASSE 25
BASEL,  CH CH-4051
Correspondent Contact JEAN-PIERRE PALMA
Regulation Number862.3320
Classification Product Code
DOA  
Subsequent Product Code
LKD  
Date Received07/24/2003
Decision Date 08/24/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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