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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
510(k) Number K950856
Device Name ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY DEFIBRILLATOR, MODEL D2000
Applicant
Zoll Medical Corp
32 Second Ave.
Burlington,  MA  01803
Applicant Contact GARY A FREEMAN
Correspondent
Zoll Medical Corp
32 Second Ave.
Burlington,  MA  01803
Correspondent Contact GARY A FREEMAN
Regulation Number870.5550
Classification Product Code
DRO  
Date Received02/27/1995
Decision Date 12/29/1995
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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