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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 K911956
Device Name ZOLL PD-1400 PACER/DEFIBRILLATOR
Applicant
Zmi Corp.
500 W. Cummings Park
Woburn,  MA  01801
Applicant Contact ALBERT T KELLEY
Correspondent
Zmi Corp.
500 W. Cummings Park
Woburn,  MA  01801
Correspondent Contact ALBERT T KELLEY
Regulation Number870.5550
Classification Product Code
DRO  
Date Received05/02/1991
Decision Date 07/31/1991
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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