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FDA 510(k)

SINGLE USE ORAL MASK, MODEL HC455A

K-Number: K023670 · 2003-06-12

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

Device Summary

SINGLE USE ORAL MASK, MODEL HC455A 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 K023670. 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 SINGLE USE ORAL MASK, MODEL HC455A?

SINGLE USE ORAL MASK, MODEL HC455A 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 K023670.

When did SINGLE USE ORAL MASK, MODEL HC455A receive FDA 510(k) clearance?

SINGLE USE ORAL MASK, MODEL HC455A received FDA 510(k) clearance on 2003-06-12, under 510(k) number K023670.

Who is the listed applicant for SINGLE USE ORAL MASK, MODEL HC455A?

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 SINGLE USE ORAL MASK, MODEL HC455A?

The FDA product code for SINGLE USE ORAL MASK, MODEL HC455A 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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