FDA 510(k)

SmartUs EXT-1M/3M

K-Number: K163121 · 2017-08-10

Decision Date2017-08-10

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SmartUs EXT-1M/3M is the device name listed in this FDA 510(k) record. The listed applicant is Telemed. It received FDA 510(k) clearance on 2017-08-10 under 510(k) number K163121. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SmartUs EXT-1M/3M?

SmartUs EXT-1M/3M is a medical device that received FDA 510(k) clearance on 2017-08-10. The listed applicant is Telemed. The 510(k) number is K163121.

When did SmartUs EXT-1M/3M receive FDA 510(k) clearance?

SmartUs EXT-1M/3M received FDA 510(k) clearance on 2017-08-10, under 510(k) number K163121.

Who is the listed applicant for SmartUs EXT-1M/3M?

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 SmartUs EXT-1M/3M?

The FDA product code for SmartUs EXT-1M/3M is IYN.

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 K161968MicrUs

Related Devices (Code: IYN)

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.