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FDA 510(k)

CPAP HUMIDIFIER, MODEL HC234 (AND RELATED ACCESSORIES)

K-Number: K040941 · 2004-06-10

ApplicantFisher & Paykel Healthcare, Ltd.
Decision Date2004-06-10
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CPAP HUMIDIFIER, MODEL HC234 (AND RELATED ACCESSORIES) 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 2004-06-10 under 510(k) number K040941. 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 HC234 (AND RELATED ACCESSORIES)?

CPAP HUMIDIFIER, MODEL HC234 (AND RELATED ACCESSORIES) is a medical device that received FDA 510(k) clearance on 2004-06-10. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K040941.

When did CPAP HUMIDIFIER, MODEL HC234 (AND RELATED ACCESSORIES) receive FDA 510(k) clearance?

CPAP HUMIDIFIER, MODEL HC234 (AND RELATED ACCESSORIES) received FDA 510(k) clearance on 2004-06-10, under 510(k) number K040941.

Who is the listed applicant for CPAP HUMIDIFIER, MODEL HC234 (AND RELATED ACCESSORIES)?

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 HC234 (AND RELATED ACCESSORIES)?

The FDA product code for CPAP HUMIDIFIER, MODEL HC234 (AND RELATED ACCESSORIES) 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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