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FDA 510(k)

ULTRASOUND LOCALIZATION SYSTEM ULS 0142

K-Number: K040741 · 2004-08-19

Decision Date2004-08-19
Product CodeLNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ULTRASOUND LOCALIZATION SYSTEM ULS 0142 is the device name listed in this FDA 510(k) record. The listed applicant is Hmt High Medical Technologies AG. It received FDA 510(k) clearance on 2004-08-19 under 510(k) number K040741. The device is classified under product code LNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRASOUND LOCALIZATION SYSTEM ULS 0142?

ULTRASOUND LOCALIZATION SYSTEM ULS 0142 is a medical device that received FDA 510(k) clearance on 2004-08-19. The listed applicant is Hmt High Medical Technologies AG. The 510(k) number is K040741.

When did ULTRASOUND LOCALIZATION SYSTEM ULS 0142 receive FDA 510(k) clearance?

ULTRASOUND LOCALIZATION SYSTEM ULS 0142 received FDA 510(k) clearance on 2004-08-19, under 510(k) number K040741.

Who is the listed applicant for ULTRASOUND LOCALIZATION SYSTEM ULS 0142?

The FDA 510(k) record lists Hmt High Medical Technologies AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRASOUND LOCALIZATION SYSTEM ULS 0142?

The FDA product code for ULTRASOUND LOCALIZATION SYSTEM ULS 0142 is LNS.

Related Clinical Trials

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: LNS)

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.

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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