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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 K922631
Device Name STATPAL II BLOOD GAS ANALYSIS SYSTEM
Applicant
Ppg Industries, Inc.
11077 N. Torrey Pines Rd.
La Jolla,  CA  92037
Applicant Contact DOUGLAS G CHRISTIAN
Correspondent
Ppg Industries, Inc.
11077 N. Torrey Pines Rd.
La Jolla,  CA  92037
Correspondent Contact DOUGLAS G CHRISTIAN
Regulation Number862.1120
Classification Product Code
CHL  
Date Received06/03/1992
Decision Date 11/10/1992
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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