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FDA 510(k)

FISHER & PAYKEL HEALTHECARE ORACLE ORAL MASK

K-Number: K023559 · 2003-06-12

ApplicantFisher & Paykel Healthcare, Ltd.
Decision Date2003-06-12
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FISHER & PAYKEL HEALTHECARE ORACLE ORAL MASK 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 2003-06-12 under 510(k) number K023559. 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 FISHER & PAYKEL HEALTHECARE ORACLE ORAL MASK?

FISHER & PAYKEL HEALTHECARE ORACLE ORAL MASK is a medical device that received FDA 510(k) clearance on 2003-06-12. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K023559.

When did FISHER & PAYKEL HEALTHECARE ORACLE ORAL MASK receive FDA 510(k) clearance?

FISHER & PAYKEL HEALTHECARE ORACLE ORAL MASK received FDA 510(k) clearance on 2003-06-12, under 510(k) number K023559.

Who is the listed applicant for FISHER & PAYKEL HEALTHECARE ORACLE ORAL MASK?

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 FISHER & PAYKEL HEALTHECARE ORACLE ORAL MASK?

The FDA product code for FISHER & PAYKEL HEALTHECARE ORACLE ORAL MASK 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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