WatchPAT300 (WP300)

Ventilatory Effort Recorder

Itamar Medical, Ltd

The following data is part of a premarket notification filed by Itamar Medical, Ltd with the FDA for Watchpat300 (wp300).

Pre-market Notification Details

Device IDK222331
510k NumberK222331
Device Name:WatchPAT300 (WP300)
ClassificationVentilatory Effort Recorder
Applicant Itamar Medical, Ltd 9 Halamish Street Casearea,  IL 3088900
ContactEfrat Litman
CorrespondentJonathan Kahan
Hogan Lovells Us Llp 553 Thirteenth Street, NW Washington,  DC  20004
Product CodeMNR  
CFR Regulation Number868.2375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-08-02
Decision Date2022-09-14

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