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FDA 510(k)

Zyter RPM

K-Number: K212622 · 2022-02-11

ApplicantZyter, Inc.
Decision Date2022-02-11
Product CodeMSX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Zyter RPM is a medical device manufactured by Zyter, Inc.. It received FDA 510(k) clearance on 2022-02-11 under approval number K212622. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zyter RPM?

Zyter RPM is a medical device that received FDA 510(k) clearance on 2022-02-11. It is manufactured by Zyter, Inc.. The 510(k) number is K212622.

When was Zyter RPM approved by the FDA?

Zyter RPM received FDA 510(k) clearance on 2022-02-11, under approval number K212622.

What company makes Zyter RPM?

Zyter RPM is manufactured by Zyter, Inc..

What is the FDA product code for Zyter RPM?

The FDA product code for Zyter RPM is MSX.

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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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