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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 K991293
Device Name EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATOR
Applicant
Fischer Medical Technologies, Inc.
12300 N. Grant
Denver,  CO  80241
Applicant Contact RONALD SHORES
Correspondent
Fischer Medical Technologies, Inc.
12300 N. Grant
Denver,  CO  80241
Correspondent Contact RONALD SHORES
Regulation Number870.1750
Classification Product Code
JOQ  
Date Received04/15/1999
Decision Date 05/05/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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