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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 K940918
Device Name I-STAT 200 PORTABLE CLINICAL ANALYZER
Applicant
I-STAT CORP.
303 COLLEGE RD. EAST
PRINCETON,  NJ  08540
Applicant Contact IMANTS R LAUKS
Correspondent
I-STAT CORP.
303 COLLEGE RD. EAST
PRINCETON,  NJ  08540
Correspondent Contact IMANTS R LAUKS
Regulation Number862.1120
Classification Product Code
CHL  
Subsequent Product Code
JGS  
Date Received02/25/1994
Decision Date 05/10/1994
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
Recalls CDRH Recalls
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