ZOLL ECG Analysis Software

Electrocardiograph

ZOLL Manufacturing Corporation

The following data is part of a premarket notification filed by Zoll Manufacturing Corporation with the FDA for Zoll Ecg Analysis Software.

Pre-market Notification Details

Device IDK182093
510k NumberK182093
Device Name:ZOLL ECG Analysis Software
ClassificationElectrocardiograph
Applicant ZOLL Manufacturing Corporation 121 Gamma Drive Pittsburgh,  PA  15238
ContactZachary Nelson
CorrespondentZachary Nelson
ZOLL Manufacturing Corporation 121 Gamma Drive Pittsburgh,  PA  15238
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-08-03
Decision Date2019-01-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00855778005333 K182093 000

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