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FDA 510(k)

F&P ICON SERIES CPAP

K-Number: K094040 · 2010-04-27

ApplicantFisher & Paykel Healthcare, Ltd.
Decision Date2010-04-27
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

F&P ICON SERIES CPAP 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 2010-04-27 under 510(k) number K094040. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the F&P ICON SERIES CPAP?

F&P ICON SERIES CPAP is a medical device that received FDA 510(k) clearance on 2010-04-27. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K094040.

When did F&P ICON SERIES CPAP receive FDA 510(k) clearance?

F&P ICON SERIES CPAP received FDA 510(k) clearance on 2010-04-27, under 510(k) number K094040.

Who is the listed applicant for F&P ICON SERIES CPAP?

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 F&P ICON SERIES CPAP?

The FDA product code for F&P ICON SERIES CPAP is BZD.

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Related Devices (Code: BZD)

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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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