FDA 510(k)

LELTEK Ultrasound Imaging System (Model: LU700 Series)

K-Number: K210432 · 2021-11-03

Decision Date2021-11-03

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

LELTEK Ultrasound Imaging System (Model: LU700 Series) is the device name listed in this FDA 510(k) record. The listed applicant is Leltek, Inc.. It received FDA 510(k) clearance on 2021-11-03 under 510(k) number K210432. 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 (Model: LU700 Series)?

LELTEK Ultrasound Imaging System (Model: LU700 Series) is a medical device that received FDA 510(k) clearance on 2021-11-03. The listed applicant is Leltek, Inc.. The 510(k) number is K210432.

When did LELTEK Ultrasound Imaging System (Model: LU700 Series) receive FDA 510(k) clearance?

LELTEK Ultrasound Imaging System (Model: LU700 Series) received FDA 510(k) clearance on 2021-11-03, under 510(k) number K210432.

Who is the listed applicant for LELTEK Ultrasound Imaging System (Model: LU700 Series)?

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 (Model: LU700 Series)?

The FDA product code for LELTEK Ultrasound Imaging System (Model: LU700 Series) 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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