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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Ion-Specific, Chloride
510(k) Number K981270
Device Name IRMA BLOOD ANALYSIS SYSTEM
Applicant
Diametrics Medical, Inc.
2658 Patton Rd.
Roseville,  MN  55113
Applicant Contact STEVE BOEH
Correspondent
Diametrics Medical, Inc.
2658 Patton Rd.
Roseville,  MN  55113
Correspondent Contact STEVE BOEH
Regulation Number862.1170
Classification Product Code
CGZ  
Subsequent Product Codes
CDS   CEM   CHL   GKG   JFP  
JGS  
Date Received04/07/1998
Decision Date 05/01/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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