OJR215 Pressure Relief Manifold

Valve, Non-rebreathing

Fisher & Paykel Healthcare Limited

The following data is part of a premarket notification filed by Fisher & Paykel Healthcare Limited with the FDA for Ojr215 Pressure Relief Manifold.

Pre-market Notification Details

Device IDK173770
510k NumberK173770
Device Name:OJR215 Pressure Relief Manifold
ClassificationValve, Non-rebreathing
Applicant Fisher & Paykel Healthcare Limited 15 Maurice Paykel Place, East Tamaki Auckland,  NZ 2013
ContactAdele Bindon
CorrespondentAdele Bindon
Fisher & Paykel Healthcare Limited 15 Maurice Paykel Place, East Tamaki Auckland,  NZ 2013
Product CodeCBP  
CFR Regulation Number868.5870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-12-11
Decision Date2019-04-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
09420012448927 K173770 000
09420012448903 K173770 000
09420012448880 K173770 000
09420012448866 K173770 000
09420012448842 K173770 000
09420012445278 K173770 000

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