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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Carbon-Dioxide, Cutaneous
510(k) Number K043357
Device Name TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009
Applicant
LINDE MEDICAL SENSORS AG
AUSTRASSE 25
BASEL,  CH 4051
Applicant Contact JEAN-PIERRE PALMA
Correspondent
LINDE MEDICAL SENSORS AG
AUSTRASSE 25
BASEL,  CH 4051
Correspondent Contact JEAN-PIERRE PALMA
Regulation Number868.2480
Classification Product Code
LKD  
Subsequent Product Code
DPZ  
Date Received12/06/2004
Decision Date 03/04/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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