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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 the device name listed in this FDA 510(k) record. The listed applicant is Fisher & Paykel Healthcare Limited. It received FDA 510(k) clearance on 2019-04-05 under 510(k) 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. The listed applicant is Fisher & Paykel Healthcare Limited. The 510(k) number is K173770.

When did OJR215 Pressure Relief Manifold receive FDA 510(k) clearance?

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

Who is the listed applicant for OJR215 Pressure Relief Manifold?

The FDA 510(k) record lists Fisher & Paykel Healthcare Limited as the applicant. This does not by itself establish the device manufacturer.

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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