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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
510(k) Number K893094
Device Name HB 1000, BRUGADA ELECTROPHYSIOLOGY SYSTEM
Applicant
Heartware Intl. Corp.
2901 Broadway
Suite 118
New York,  NY  10025
Applicant Contact GERALD B SEERY
Correspondent
Heartware Intl. Corp.
2901 Broadway
Suite 118
New York,  NY  10025
Correspondent Contact GERALD B SEERY
Regulation Number870.1750
Classification Product Code
JOQ  
Date Received04/28/1989
Decision Date 10/02/1989
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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