FDA 510(k)

SAFIRA

K-Number: K230083 · 2023-10-31

Decision Date2023-10-31

Product CodeFRN

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SAFIRA is the device name listed in this FDA 510(k) record. The listed applicant is Medovate Limited. It received FDA 510(k) clearance on 2023-10-31 under 510(k) number K230083. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAFIRA?

SAFIRA is a medical device that received FDA 510(k) clearance on 2023-10-31. The listed applicant is Medovate Limited. The 510(k) number is K230083.

When did SAFIRA receive FDA 510(k) clearance?

SAFIRA received FDA 510(k) clearance on 2023-10-31, under 510(k) number K230083.

Who is the listed applicant for SAFIRA?

The FDA 510(k) record lists Medovate Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAFIRA?

The FDA product code for SAFIRA is FRN.

Related Devices (Code: FRN)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.