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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 K855015
Device Name NONINVASIVE TEMP. PACEMAKER NTP-1000
Applicant
ZMI CORP.
325 VASSAR ST.
CAMBRIDGE,  MA  02139
Applicant Contact ROLF S STUTZ
Correspondent
ZMI CORP.
325 VASSAR ST.
CAMBRIDGE,  MA  02139
Correspondent Contact ROLF S STUTZ
Regulation Number870.5550
Classification Product Code
DRO  
Date Received12/16/1985
Decision Date 03/31/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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