FDA 510(k)

Leltek Ultrasound Imaging System

K-Number: K191235 · 2020-02-12

Decision Date2020-02-12

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Leltek Ultrasound Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Leltek, Inc.. It received FDA 510(k) clearance on 2020-02-12 under 510(k) number K191235. 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 Leltek Ultrasound Imaging System?

Leltek Ultrasound Imaging System is a medical device that received FDA 510(k) clearance on 2020-02-12. The listed applicant is Leltek, Inc.. The 510(k) number is K191235.

When did Leltek Ultrasound Imaging System receive FDA 510(k) clearance?

Leltek Ultrasound Imaging System received FDA 510(k) clearance on 2020-02-12, under 510(k) number K191235.

Who is the listed applicant for Leltek Ultrasound Imaging System?

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

What is the FDA product code for Leltek Ultrasound Imaging System?

The FDA product code for Leltek Ultrasound Imaging System is IYN.

Other records listing Leltek, Inc. 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.

Related Devices (Code: IYN)

Official Source

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