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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 K924758
Device Name DMI BLOOD GAS ANALYZER/CARTRIDGE
Applicant
Diamond Medical, Inc.
2658 Patton Rd.
Roseville,  MN  55113
Applicant Contact WALTER L SEMBROWICH
Correspondent
Diamond Medical, Inc.
2658 Patton Rd.
Roseville,  MN  55113
Correspondent Contact WALTER L SEMBROWICH
Regulation Number862.1120
Classification Product Code
CHL  
Date Received09/23/1992
Decision Date 12/03/1992
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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