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FDA 510(k)

CPAP HUMIDIFIER, MODEL HC238JHU

K-Number: K050904 · 2005-05-25

ApplicantFisher & Paykel Healthcare, Ltd.
Decision Date2005-05-25
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CPAP HUMIDIFIER, MODEL HC238JHU 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 2005-05-25 under 510(k) number K050904. 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 CPAP HUMIDIFIER, MODEL HC238JHU?

CPAP HUMIDIFIER, MODEL HC238JHU is a medical device that received FDA 510(k) clearance on 2005-05-25. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K050904.

When did CPAP HUMIDIFIER, MODEL HC238JHU receive FDA 510(k) clearance?

CPAP HUMIDIFIER, MODEL HC238JHU received FDA 510(k) clearance on 2005-05-25, under 510(k) number K050904.

Who is the listed applicant for CPAP HUMIDIFIER, MODEL HC238JHU?

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 CPAP HUMIDIFIER, MODEL HC238JHU?

The FDA product code for CPAP HUMIDIFIER, MODEL HC238JHU is 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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