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FDA 510(k)

Model 9160 VitaloQUB

K-Number: K223818 · 2023-05-25

ApplicantVitalograph Ireland, Ltd.
Decision Date2023-05-25
Product CodeJEH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Model 9160 VitaloQUB is a medical device manufactured by Vitalograph Ireland, Ltd.. It received FDA 510(k) clearance on 2023-05-25 under approval number K223818. The device is classified under product code JEH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Model 9160 VitaloQUB?

Model 9160 VitaloQUB is a medical device that received FDA 510(k) clearance on 2023-05-25. It is manufactured by Vitalograph Ireland, Ltd.. The 510(k) number is K223818.

When was Model 9160 VitaloQUB approved by the FDA?

Model 9160 VitaloQUB received FDA 510(k) clearance on 2023-05-25, under approval number K223818.

What company makes Model 9160 VitaloQUB?

Model 9160 VitaloQUB is manufactured by Vitalograph Ireland, Ltd..

What is the FDA product code for Model 9160 VitaloQUB?

The FDA product code for Model 9160 VitaloQUB is JEH.

Other Devices by Vitalograph Ireland, Ltd.

K201562Spirotrac K200550Vitalograph Model 2120 In2itive eDiary K221030Model 9100 PFT/DICO K212938Vitalograph Model 6000 Alpha

Related Devices (Code: JEH)

K240706PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+)Ganshorn Medizin Electronic GmbH

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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