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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 K031814
Device Name STATCO2METER, MODEL 10-55372
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  
Subsequent Product Code
CAP  
Date Received06/12/2003
Decision Date 08/14/2003
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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