FDA 510(k)

Model 9160 VitaloQUB

K-Number: K223818 · 2023-05-25

Decision Date2023-05-25

Product CodeJEH

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Model 9160 VitaloQUB is the device name listed in this FDA 510(k) record. The listed applicant is Vitalograph Ireland, Ltd.. It received FDA 510(k) clearance on 2023-05-25 under 510(k) 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. The listed applicant is Vitalograph Ireland, Ltd.. The 510(k) number is K223818.

When did Model 9160 VitaloQUB receive FDA 510(k) clearance?

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

Who is the listed applicant for Model 9160 VitaloQUB?

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

What is the FDA product code for Model 9160 VitaloQUB?

The FDA product code for Model 9160 VitaloQUB is JEH.

Other records listing Vitalograph Ireland, 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.

K221030Model 9100 PFT/DICO K212938Vitalograph Model 6000 Alpha K201562Spirotrac K200550Vitalograph Model 2120 In2itive eDiary K160253Vitalograph Model 6300 micro

Related Devices (Code: JEH)

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

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.