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FDA 510(k)

LiteWalk

K-Number: K192607 · 2019-12-19

Decision Date2019-12-19
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

LiteWalk is the device name listed in this FDA 510(k) record. The listed applicant is Viasonix , Ltd.. It received FDA 510(k) clearance on 2019-12-19 under 510(k) number K192607. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LiteWalk?

LiteWalk is a medical device that received FDA 510(k) clearance on 2019-12-19. The listed applicant is Viasonix , Ltd.. The 510(k) number is K192607.

When did LiteWalk receive FDA 510(k) clearance?

LiteWalk received FDA 510(k) clearance on 2019-12-19, under 510(k) number K192607.

Who is the listed applicant for LiteWalk?

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

What is the FDA product code for LiteWalk?

The FDA product code for LiteWalk is IRP.

Other records listing Viasonix , Ltd. 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: IRP)

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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