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FDA 510(k)

Polaris Valve Electronic Reading Instrument

K-Number: K222422 · 2023-02-02

ApplicantSophysa
Decision Date2023-02-02
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Polaris Valve Electronic Reading Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Sophysa. It received FDA 510(k) clearance on 2023-02-02 under 510(k) number K222422. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Polaris Valve Electronic Reading Instrument?

Polaris Valve Electronic Reading Instrument is a medical device that received FDA 510(k) clearance on 2023-02-02. The listed applicant is Sophysa. The 510(k) number is K222422.

When did Polaris Valve Electronic Reading Instrument receive FDA 510(k) clearance?

Polaris Valve Electronic Reading Instrument received FDA 510(k) clearance on 2023-02-02, under 510(k) number K222422.

Who is the listed applicant for Polaris Valve Electronic Reading Instrument?

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

What is the FDA product code for Polaris Valve Electronic Reading Instrument?

The FDA product code for Polaris Valve Electronic Reading Instrument is JXG.

Other records listing Sophysa 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: JXG)

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.

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