FDA 510(k)

MicrUs

K-Number: K161968 · 2016-11-03

Decision Date2016-11-03

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MicrUs is the device name listed in this FDA 510(k) record. The listed applicant is Telemed. It received FDA 510(k) clearance on 2016-11-03 under 510(k) number K161968. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MicrUs?

MicrUs is a medical device that received FDA 510(k) clearance on 2016-11-03. The listed applicant is Telemed. The 510(k) number is K161968.

When did MicrUs receive FDA 510(k) clearance?

MicrUs received FDA 510(k) clearance on 2016-11-03, under 510(k) number K161968.

Who is the listed applicant for MicrUs?

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

What is the FDA product code for MicrUs?

The FDA product code for MicrUs is IYO.

Other records listing Telemed 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.

K211248ArtUs K163121SmartUs EXT-1M/3M

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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.