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FDA 510(k)

VX650

K-Number: K202221 · 2021-01-29

ApplicantLuneau Technology Operations
Decision Date2021-01-29
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VX650 is a medical device manufactured by Luneau Technology Operations. It received FDA 510(k) clearance on 2021-01-29 under approval number K202221. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VX650?

VX650 is a medical device that received FDA 510(k) clearance on 2021-01-29. It is manufactured by Luneau Technology Operations. The 510(k) number is K202221.

When was VX650 approved by the FDA?

VX650 received FDA 510(k) clearance on 2021-01-29, under approval number K202221.

What company makes VX650?

VX650 is manufactured by Luneau Technology Operations.

What is the FDA product code for VX650?

The FDA product code for VX650 is HKI.

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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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