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FDA 510(k)

PRESSURE MANIFOLD, MODEL BC 110

K-Number: K040366 · 2004-03-04

ApplicantFisher & Paykel Healthcare, Ltd.
Decision Date2004-03-04
Product CodeCBP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PRESSURE MANIFOLD, MODEL BC 110 is the device name listed in this FDA 510(k) record. The listed applicant is Fisher & Paykel Healthcare, Ltd.. It received FDA 510(k) clearance on 2004-03-04 under 510(k) number K040366. 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 PRESSURE MANIFOLD, MODEL BC 110?

PRESSURE MANIFOLD, MODEL BC 110 is a medical device that received FDA 510(k) clearance on 2004-03-04. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K040366.

When did PRESSURE MANIFOLD, MODEL BC 110 receive FDA 510(k) clearance?

PRESSURE MANIFOLD, MODEL BC 110 received FDA 510(k) clearance on 2004-03-04, under 510(k) number K040366.

Who is the listed applicant for PRESSURE MANIFOLD, MODEL BC 110?

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

What is the FDA product code for PRESSURE MANIFOLD, MODEL BC 110?

The FDA product code for PRESSURE MANIFOLD, MODEL BC 110 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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