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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 K953935
Device Name MED-TECH CLINICAL BLOOD GAS
Applicant
Medical Technical Gases Inc..
20 Hall St.
Medford,  MA  02155
Applicant Contact RAMESH V KAPUR
Correspondent
Medical Technical Gases Inc..
20 Hall St.
Medford,  MA  02155
Correspondent Contact RAMESH V KAPUR
Regulation Number862.1120
Classification Product Code
CHL  
Date Received08/18/1995
Decision Date 11/20/1995
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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