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FDA 510(k)

LIGHTMED Ultrasound System

K-Number: K183173 · 2019-07-01

ApplicantLightmed USA, Inc.
Decision Date2019-07-01
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LIGHTMED Ultrasound System is a medical device manufactured by Lightmed USA, Inc.. It received FDA 510(k) clearance on 2019-07-01 under approval number K183173. 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 LIGHTMED Ultrasound System?

LIGHTMED Ultrasound System is a medical device that received FDA 510(k) clearance on 2019-07-01. It is manufactured by Lightmed USA, Inc.. The 510(k) number is K183173.

When was LIGHTMED Ultrasound System approved by the FDA?

LIGHTMED Ultrasound System received FDA 510(k) clearance on 2019-07-01, under approval number K183173.

What company makes LIGHTMED Ultrasound System?

LIGHTMED Ultrasound System is manufactured by Lightmed USA, Inc..

What is the FDA product code for LIGHTMED Ultrasound System?

The FDA product code for LIGHTMED Ultrasound System is IYO.

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Other Devices by Lightmed USA, Inc.

K170761LIGHTSonic BUBM

Related Devices (Code: IYO)

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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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