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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 K850360
Device Name ESCHWEILER SYSTEM 2000 - GLOOD GAS ANALYZERS
Applicant
Text Tech Corp.
4801 Woodway Dr.
One Woodway Bldg. #300 E.
Houston,  TX  77056
Applicant Contact SANDERSON
Correspondent
Text Tech Corp.
4801 Woodway Dr.
One Woodway Bldg. #300 E.
Houston,  TX  77056
Correspondent Contact SANDERSON
Regulation Number862.1120
Classification Product Code
CHL  
Date Received01/30/1985
Decision Date 04/17/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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