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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 K173439
Device Name Bloom2 Programmable Electrophysiology Stimulator
Applicant
Fischer Medical
3990 Youngfield St.
Wheat Ridge,  CO  80033
Applicant Contact Wes Rogers
Correspondent
Hart Consulting, LLC
615 Reid Place
Castle Rock,  CO  80108
Correspondent Contact Charles Mike Hart
Regulation Number870.1750
Classification Product Code
JOQ  
Date Received11/03/2017
Decision Date 03/29/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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