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FDA 510(k)

HC604 CPAP HUMIDIFIER

K-Number: K041900 · 2004-08-31

ApplicantFisher & Paykel Healthcare, Ltd.
Decision Date2004-08-31
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HC604 CPAP HUMIDIFIER 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 2004-08-31 under 510(k) number K041900. 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 HC604 CPAP HUMIDIFIER?

HC604 CPAP HUMIDIFIER is a medical device that received FDA 510(k) clearance on 2004-08-31. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K041900.

When did HC604 CPAP HUMIDIFIER receive FDA 510(k) clearance?

HC604 CPAP HUMIDIFIER received FDA 510(k) clearance on 2004-08-31, under 510(k) number K041900.

Who is the listed applicant for HC604 CPAP HUMIDIFIER?

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 HC604 CPAP HUMIDIFIER?

The FDA product code for HC604 CPAP HUMIDIFIER 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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