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FDA 510(k)

ORACLE ORAL MASK, MODEL HC451A

K-Number: K033087 · 2004-01-14

ApplicantFisher & Paykel Healthcare, Ltd.
Decision Date2004-01-14
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ORACLE ORAL MASK, MODEL HC451A 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 2004-01-14 under 510(k) number K033087. 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 ORACLE ORAL MASK, MODEL HC451A?

ORACLE ORAL MASK, MODEL HC451A is a medical device that received FDA 510(k) clearance on 2004-01-14. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K033087.

When did ORACLE ORAL MASK, MODEL HC451A receive FDA 510(k) clearance?

ORACLE ORAL MASK, MODEL HC451A received FDA 510(k) clearance on 2004-01-14, under 510(k) number K033087.

Who is the listed applicant for ORACLE ORAL MASK, MODEL HC451A?

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 ORACLE ORAL MASK, MODEL HC451A?

The FDA product code for ORACLE ORAL MASK, MODEL HC451A 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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