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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 K792230
Device Name AVL MODEL 940 AUTOMATIC PH/BLOOD GAS
Applicant
Gauntlet Technology Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Gauntlet Technology Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1120
Classification Product Code
CHL  
Date Received11/05/1979
Decision Date 12/31/1979
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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