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FDA 510(k)

KONG-TL VBR System, KONG-C VBR System

K-Number: K200235 · 2020-05-29

ApplicantIcotec AG
Decision Date2020-05-29
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KONG-TL VBR System, KONG-C VBR System is a medical device manufactured by Icotec AG. It received FDA 510(k) clearance on 2020-05-29 under approval number K200235. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KONG-TL VBR System, KONG-C VBR System?

KONG-TL VBR System, KONG-C VBR System is a medical device that received FDA 510(k) clearance on 2020-05-29. It is manufactured by Icotec AG. The 510(k) number is K200235.

When was KONG-TL VBR System, KONG-C VBR System approved by the FDA?

KONG-TL VBR System, KONG-C VBR System received FDA 510(k) clearance on 2020-05-29, under approval number K200235.

What company makes KONG-TL VBR System, KONG-C VBR System?

KONG-TL VBR System, KONG-C VBR System is manufactured by Icotec AG.

What is the FDA product code for KONG-TL VBR System, KONG-C VBR System?

The FDA product code for KONG-TL VBR System, KONG-C VBR System is MQP.

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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.