H3+ Holter Recorder

Electrocardiograph, Ambulatory (without Analysis)

MORTARA INSTRUMENT, INC

The following data is part of a premarket notification filed by Mortara Instrument, Inc with the FDA for H3+ Holter Recorder.

Pre-market Notification Details

Device IDK152626
510k NumberK152626
Device Name:H3+ Holter Recorder
ClassificationElectrocardiograph, Ambulatory (without Analysis)
Applicant MORTARA INSTRUMENT, INC 7865 NORTH 86TH ST. Milwaukee,  WI  53224
ContactMargaret Mucha
CorrespondentMargaret Mucha
MORTARA INSTRUMENT, INC 7865 NORTH 86TH ST. Milwaukee,  WI  53224
Product CodeMWJ  
CFR Regulation Number870.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-09-15
Decision Date2016-02-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00812345025064 K152626 000
00812345023077 K152626 000
00812345023084 K152626 000
00812345024982 K152626 000
00812345024999 K152626 000
00812345025002 K152626 000
00812345025026 K152626 000
00812345025033 K152626 000
00812345025040 K152626 000
00812345025057 K152626 000
00732094282498 K152626 000

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