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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controls For Blood-Gases, (Assayed And Unassayed)
510(k) Number K980135
Device Name QUALICHECK5+ MODELS S7730, S7740, S7750, S7760
Applicant
RADIOMETER AMERICA, INC.
810 SHARON DR.
WESTLAKE,  OH  44145 -1598
Applicant Contact DONALD L BAKER
Correspondent
RADIOMETER AMERICA, INC.
810 SHARON DR.
WESTLAKE,  OH  44145 -1598
Correspondent Contact DONALD L BAKER
Regulation Number862.1660
Classification Product Code
JJS  
Date Received01/15/1998
Decision Date 01/28/1998
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
Recalls CDRH Recalls
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