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FDA 510(k)

Infinix-i, INFX-8000V, V7.0

K-Number: K172863 · 2017-12-14

ApplicantToshibamedical Systems Corporation
Decision Date2017-12-14
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Infinix-i, INFX-8000V, V7.0 is the device name listed in this FDA 510(k) record. The listed applicant is Toshibamedical Systems Corporation. It received FDA 510(k) clearance on 2017-12-14 under 510(k) number K172863. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Infinix-i, INFX-8000V, V7.0?

Infinix-i, INFX-8000V, V7.0 is a medical device that received FDA 510(k) clearance on 2017-12-14. The listed applicant is Toshibamedical Systems Corporation. The 510(k) number is K172863.

When did Infinix-i, INFX-8000V, V7.0 receive FDA 510(k) clearance?

Infinix-i, INFX-8000V, V7.0 received FDA 510(k) clearance on 2017-12-14, under 510(k) number K172863.

Who is the listed applicant for Infinix-i, INFX-8000V, V7.0?

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

What is the FDA product code for Infinix-i, INFX-8000V, V7.0?

The FDA product code for Infinix-i, INFX-8000V, V7.0 is OWB.

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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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