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FDA 510(k)

FISHER AND PAYKEL HEALTHCARE ZEST NASAL MASK

K-Number: K080209 · 2008-09-12

ApplicantFisher & Paykel Healthcare, Ltd.
Decision Date2008-09-12
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FISHER AND PAYKEL HEALTHCARE ZEST NASAL 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 2008-09-12 under 510(k) number K080209. 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 AND PAYKEL HEALTHCARE ZEST NASAL MASK?

FISHER AND PAYKEL HEALTHCARE ZEST NASAL MASK is a medical device that received FDA 510(k) clearance on 2008-09-12. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K080209.

When did FISHER AND PAYKEL HEALTHCARE ZEST NASAL MASK receive FDA 510(k) clearance?

FISHER AND PAYKEL HEALTHCARE ZEST NASAL MASK received FDA 510(k) clearance on 2008-09-12, under 510(k) number K080209.

Who is the listed applicant for FISHER AND PAYKEL HEALTHCARE ZEST NASAL 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 AND PAYKEL HEALTHCARE ZEST NASAL MASK?

The FDA product code for FISHER AND PAYKEL HEALTHCARE ZEST NASAL 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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