Watch-PAT200U

Ventilatory Effort Recorder

ITAMAR MEDICAL, LTD.

The following data is part of a premarket notification filed by Itamar Medical, Ltd. with the FDA for Watch-pat200u.

Pre-market Notification Details

Device IDK161579
510k NumberK161579
Device Name:Watch-PAT200U
ClassificationVentilatory Effort Recorder
Applicant ITAMAR MEDICAL, LTD. 9 HALAMISH ST. Caesarea,  IL 3088900
ContactKoby Sheffy
CorrespondentJonathan Kahan
HOGAN LOVELLS US LLP 555 13th Street, NW Washington,  DC  20004 -1109
Product CodeMNR  
CFR Regulation Number868.2375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-06-07
Decision Date2017-02-24
Summary:summary

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