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FDA 510(k)

KONG®-TL VBR System and KONG® C VBR System

K-Number: K232790 · 2024-04-04

ApplicantIcotec AG
Decision Date2024-04-04
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KONG®-TL VBR System and KONG® C VBR System is the device name listed in this FDA 510(k) record. The listed applicant is Icotec AG. It received FDA 510(k) clearance on 2024-04-04 under 510(k) number K232790. 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 and KONG® C VBR System?

KONG®-TL VBR System and KONG® C VBR System is a medical device that received FDA 510(k) clearance on 2024-04-04. The listed applicant is Icotec AG. The 510(k) number is K232790.

When did KONG®-TL VBR System and KONG® C VBR System receive FDA 510(k) clearance?

KONG®-TL VBR System and KONG® C VBR System received FDA 510(k) clearance on 2024-04-04, under 510(k) number K232790.

Who is the listed applicant for KONG®-TL VBR System and KONG® C VBR System?

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

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

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

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Related Devices (Code: MQP)

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.

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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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