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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reservoir, Blood, Cardiopulmonary Bypass
510(k) Number K930154
Device Name EL2-SERIES BLOOD COLLECTION REERVOIR
Applicant
ELECTROMEDICS, INC.
7337 SOUTH REVERE PKWY.
ENGLEWOOD,  CO  80112
Applicant Contact HAROLD W BRYAN
Correspondent
ELECTROMEDICS, INC.
7337 SOUTH REVERE PKWY.
ENGLEWOOD,  CO  80112
Correspondent Contact HAROLD W BRYAN
Regulation Number870.4400
Classification Product Code
DTN  
Date Received01/13/1993
Decision Date 07/01/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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