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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
510(k) Number K003982
Device Name TEMPERATURE FUNCTION, MODEL 9500 MULTIGAS MONITOR
Applicant
MAGNETIC RESONANCE EQUIPMENT CORP.
6 WASHINGTON AVE.
BAY SHORE,  NY  11706
Applicant Contact G. RONALD MORRIS
Correspondent
MAGNETIC RESONANCE EQUIPMENT CORP.
6 WASHINGTON AVE.
BAY SHORE,  NY  11706
Correspondent Contact G. RONALD MORRIS
Regulation Number868.1400
Classification Product Code
CCK  
Date Received12/22/2000
Decision Date 01/26/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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