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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
510(k) Number K974526
Device Name EASYBLOOD GAS ANALYZER
Applicant
Medica Corp.
14 Deangelo Dr.
Bedford,  MA  01730
Applicant Contact Photios Makris
Correspondent
Medica Corp.
14 Deangelo Dr.
Bedford,  MA  01730
Correspondent Contact Photios Makris
Regulation Number862.1120
Classification Product Code
CHL  
Date Received12/02/1997
Decision Date 02/05/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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