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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tester, Defibrillator
510(k) Number K880780
Device Name HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG
Applicant
First Medical Devices Corp.
2445 140th Ave. NE Suite 150
(Per Do, Firm Oob)
Bellevue,  WA  98005
Applicant Contact BRUCE HAGGAR
Correspondent
First Medical Devices Corp.
2445 140th Ave. NE Suite 150
(Per Do, Firm Oob)
Bellevue,  WA  98005
Correspondent Contact BRUCE HAGGAR
Regulation Number870.5325
Classification Product Code
DRL  
Date Received02/26/1988
Decision Date 05/12/1988
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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