ZOLL NTP-1200 PACER/DEFIBRILLATOR

Pacemaker, Cardiac, External Transcutaneous (non-invasive)

ZMI CORP.

The following data is part of a premarket notification filed by Zmi Corp. with the FDA for Zoll Ntp-1200 Pacer/defibrillator.

Pre-market Notification Details

Device IDK873402
510k NumberK873402
Device Name:ZOLL NTP-1200 PACER/DEFIBRILLATOR
ClassificationPacemaker, Cardiac, External Transcutaneous (non-invasive)
Applicant ZMI CORP. 325 VASSAR ST. Cambridge,  MA  02139
ContactPaul A Levesque
CorrespondentPaul A Levesque
ZMI CORP. 325 VASSAR ST. Cambridge,  MA  02139
Product CodeDRO  
CFR Regulation Number870.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-24
Decision Date1987-11-23

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