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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dc-Defibrillator, Low-Energy, (Including Paddles)
510(k) Number K913484
Device Name ZOLL D-900 DEFIBRILLATOR
Applicant
Zmi Corp.
500 W. Cummings Park
Woburn,  MA  01801
Applicant Contact ROD BOUCHER
Correspondent
Zmi Corp.
500 W. Cummings Park
Woburn,  MA  01801
Correspondent Contact ROD BOUCHER
Regulation Number870.5300
Classification Product Code
LDD  
Date Received08/06/1991
Decision Date 12/16/1991
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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