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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 a medical device manufactured by Sophysa. It received FDA 510(k) clearance on 2023-02-02 under approval 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. It is manufactured by Sophysa. The 510(k) number is K222422.

When was Polaris Valve Electronic Reading Instrument approved by the FDA?

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

What company makes Polaris Valve Electronic Reading Instrument?

Polaris Valve Electronic Reading Instrument is manufactured by Sophysa.

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

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

Related Clinical Trials

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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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