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FDA 510(k)

F&P Solo Mask Range

K-Number: K223696 · 2023-05-17

ApplicantFisher & Paykel Healthcare, Ltd.
Decision Date2023-05-17
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

F&P Solo Mask Range 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 2023-05-17 under 510(k) number K223696. 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 F&P Solo Mask Range?

F&P Solo Mask Range is a medical device that received FDA 510(k) clearance on 2023-05-17. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K223696.

When did F&P Solo Mask Range receive FDA 510(k) clearance?

F&P Solo Mask Range received FDA 510(k) clearance on 2023-05-17, under 510(k) number K223696.

Who is the listed applicant for F&P Solo Mask Range?

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 F&P Solo Mask Range?

The FDA product code for F&P Solo Mask Range is BZD.

Other records listing Fisher & Paykel Healthcare, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: BZD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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