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FDA 510(k)

FLEXIFIL SERIES HC431 FULL FACE MASK, MODEL HC431A

K-Number: K040506 · 2004-05-05

ApplicantFisher & Paykel Healthcare, Ltd.
Decision Date2004-05-05
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FLEXIFIL SERIES HC431 FULL FACE MASK, MODEL HC431A 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 2004-05-05 under 510(k) number K040506. 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 FLEXIFIL SERIES HC431 FULL FACE MASK, MODEL HC431A?

FLEXIFIL SERIES HC431 FULL FACE MASK, MODEL HC431A is a medical device that received FDA 510(k) clearance on 2004-05-05. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K040506.

When did FLEXIFIL SERIES HC431 FULL FACE MASK, MODEL HC431A receive FDA 510(k) clearance?

FLEXIFIL SERIES HC431 FULL FACE MASK, MODEL HC431A received FDA 510(k) clearance on 2004-05-05, under 510(k) number K040506.

Who is the listed applicant for FLEXIFIL SERIES HC431 FULL FACE MASK, MODEL HC431A?

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 FLEXIFIL SERIES HC431 FULL FACE MASK, MODEL HC431A?

The FDA product code for FLEXIFIL SERIES HC431 FULL FACE MASK, MODEL HC431A 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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