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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 K862543
Device Name DYNEX CO2/2000, CO2 ANALYZER
Applicant
Analytical Products, Inc.
511 Taylor Way
Belmont,  CA  94002 -
Applicant Contact RONALD B SMERNOFF
Correspondent
Analytical Products, Inc.
511 Taylor Way
Belmont,  CA  94002 -
Correspondent Contact RONALD B SMERNOFF
Regulation Number868.1400
Classification Product Code
CCK  
Date Received07/03/1986
Decision Date 07/15/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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