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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 the device name listed in this FDA 510(k) record. The listed applicant is Zyter, Inc.. It received FDA 510(k) clearance on 2022-02-11 under 510(k) 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. The listed applicant is Zyter, Inc.. The 510(k) number is K212622.

When did Zyter RPM receive FDA 510(k) clearance?

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

Who is the listed applicant for Zyter RPM?

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

What is the FDA product code for Zyter RPM?

The FDA product code for Zyter RPM is MSX.

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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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