Cleared Traditional

OJR215 Pressure Relief Manifold

K173770 · Fisher & Paykel Healthcare Limited · Anesthesiology
Apr 2019
Decision
480d
Days
Class 2
Risk

About This 510(k) Submission

K173770 is an FDA 510(k) clearance for the OJR215 Pressure Relief Manifold, a Valve, Non-rebreathing (Class II — Special Controls, product code CBP), submitted by Fisher & Paykel Healthcare Limited (Auckland, NZ). The FDA issued a Cleared decision on April 5, 2019, 480 days after receiving the submission on December 11, 2017. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5870.

Submission Details

510(k) Number K173770 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 2017
Decision Date April 05, 2019
Days to Decision 480 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CBP — Valve, Non-rebreathing
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5870

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