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FDA 510(k)

SmartUs EXT-1M/3M

K-Number: K163121 · 2017-08-10

ApplicantTelemed
Decision Date2017-08-10
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SmartUs EXT-1M/3M is a medical device manufactured by Telemed. It received FDA 510(k) clearance on 2017-08-10 under approval 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. It is manufactured by Telemed. The 510(k) number is K163121.

When was SmartUs EXT-1M/3M approved by the FDA?

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

What company makes SmartUs EXT-1M/3M?

SmartUs EXT-1M/3M is manufactured by Telemed.

What is the FDA product code for SmartUs EXT-1M/3M?

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

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Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 40610624 Impact of a novel smartphone application for remote monitoring of gestational diabetes on glycaemic control and birth outcomes: a pilot observational study. Scientific reports (2025) PMID: 40085833 The Measurement of Vital Signs in Pediatric Patients by Lifelight Software in Comparison to the Standard of Care: Protocol for the VISION-Junior Observational Study. JMIR research protocols (2025) PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025)

Other Devices by Telemed

K161968MicrUs K211248ArtUs

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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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