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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 K873402
Device Name ZOLL NTP-1200 PACER/DEFIBRILLATOR
Applicant
Zmi Corp.
325 Vassar St.
Cambridge,  MA  02139
Applicant Contact PAUL A LEVESQUE
Correspondent
Zmi Corp.
325 Vassar St.
Cambridge,  MA  02139
Correspondent Contact PAUL A LEVESQUE
Regulation Number870.5550
Classification Product Code
DRO  
Date Received08/24/1987
Decision Date 11/23/1987
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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