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FDA 510(k)

LSVT C OR LSVT COMPANION, MODEL V.1

K-Number: K091682 · 2009-08-20

Decision Date2009-08-20
Product CodeLEZ
DecisionSubstantially Equivalent

Device Summary

LSVT C OR LSVT COMPANION, MODEL V.1 is the device name listed in this FDA 510(k) record. The listed applicant is Lsvt Global, LLC. It received FDA 510(k) clearance on 2009-08-20 under 510(k) number K091682. The device is classified under product code LEZ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LSVT C OR LSVT COMPANION, MODEL V.1?

LSVT C OR LSVT COMPANION, MODEL V.1 is a medical device that received FDA 510(k) clearance on 2009-08-20. The listed applicant is Lsvt Global, LLC. The 510(k) number is K091682.

When did LSVT C OR LSVT COMPANION, MODEL V.1 receive FDA 510(k) clearance?

LSVT C OR LSVT COMPANION, MODEL V.1 received FDA 510(k) clearance on 2009-08-20, under 510(k) number K091682.

Who is the listed applicant for LSVT C OR LSVT COMPANION, MODEL V.1?

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

What is the FDA product code for LSVT C OR LSVT COMPANION, MODEL V.1?

The FDA product code for LSVT C OR LSVT COMPANION, MODEL V.1 is LEZ.

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: LEZ)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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