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FDA 510(k)

OJR215 Pressure Relief Manifold

K-Number: K173770 · 2019-04-05

ApplicantFisher & Paykel Healthcare Limited
Decision Date2019-04-05
Product CodeCBP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OJR215 Pressure Relief Manifold is a medical device manufactured by Fisher & Paykel Healthcare Limited. It received FDA 510(k) clearance on 2019-04-05 under approval number K173770. The device is classified under product code CBP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OJR215 Pressure Relief Manifold?

OJR215 Pressure Relief Manifold is a medical device that received FDA 510(k) clearance on 2019-04-05. It is manufactured by Fisher & Paykel Healthcare Limited. The 510(k) number is K173770.

When was OJR215 Pressure Relief Manifold approved by the FDA?

OJR215 Pressure Relief Manifold received FDA 510(k) clearance on 2019-04-05, under approval number K173770.

What company makes OJR215 Pressure Relief Manifold?

OJR215 Pressure Relief Manifold is manufactured by Fisher & Paykel Healthcare Limited.

What is the FDA product code for OJR215 Pressure Relief Manifold?

The FDA product code for OJR215 Pressure Relief Manifold is CBP.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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