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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Blood, Cardiopulmonary Bypass, Arterial Line
510(k) Number K910935
Device Name MODIFIED PYROGEN TESTING
Applicant
Electromedics, Inc.
7337 S. Revere Pkwy.
Englewood,  CO  80112
Applicant Contact HAROLD W BRYAN
Correspondent
Electromedics, Inc.
7337 S. Revere Pkwy.
Englewood,  CO  80112
Correspondent Contact HAROLD W BRYAN
Regulation Number870.4260
Classification Product Code
DTM  
Date Received02/14/1991
Decision Date 05/16/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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