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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
510(k) Number K991644
Device Name MICROGAS 7650 TRANSCUTANEOUS MONITOR
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 Number868.2500
Classification Product Code
KLK  
Date Received05/13/1999
Decision Date 05/21/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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