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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 K945240
Device Name IRMA BLOOD ANALYSIS SYSTEM
Applicant
DIAMETRICS MEDICAL, INC.
2658 PATTON RD.
SAINT PAUL,  MN  55113
Applicant Contact WALTER L SEMBROWICH
Correspondent
DIAMETRICS MEDICAL, INC.
2658 PATTON RD.
SAINT PAUL,  MN  55113
Correspondent Contact WALTER L SEMBROWICH
Regulation Number862.1120
Classification Product Code
CHL  
Subsequent Product Codes
CEM   GKG   JFP   JGS  
Date Received10/27/1994
Decision Date 01/05/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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