K-number	K173770
Device name	OJR215 Pressure Relief Manifold
Applicant	Fisher & Paykel Healthcare Limited
Product code	CBP
Device class	Class II
Decision date	Apr 5, 2019
Decision	Substantially Equivalent
Regulation	868.5870

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Source

View the full FDA submission: accessdata.fda.gov

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OJR215 Pressure Relief Manifold

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