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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 K031411
Device Name MINI STATCO2 CO2 DETECTOR, MODEL 10-55371
Applicant
MERCURY MEDICAL
11300 49TH ST. NORTH
CLEARWATER,  FL  33762 -4800
Applicant Contact WAYNE GLOVER
Correspondent
MERCURY MEDICAL
11300 49TH ST. NORTH
CLEARWATER,  FL  33762 -4800
Correspondent Contact WAYNE GLOVER
Regulation Number868.1400
Classification Product Code
CCK  
Date Received05/05/2003
Decision Date 07/30/2003
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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