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FDA 510(k)

Infinix, INFX-8000V, V6.35

K-Number: K162614 · 2016-10-17

ApplicantToshibamedical Systems Corporation
Decision Date2016-10-17
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Infinix, INFX-8000V, V6.35 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 2016-10-17 under 510(k) number K162614. 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, INFX-8000V, V6.35?

Infinix, INFX-8000V, V6.35 is a medical device that received FDA 510(k) clearance on 2016-10-17. The listed applicant is Toshibamedical Systems Corporation. The 510(k) number is K162614.

When did Infinix, INFX-8000V, V6.35 receive FDA 510(k) clearance?

Infinix, INFX-8000V, V6.35 received FDA 510(k) clearance on 2016-10-17, under 510(k) number K162614.

Who is the listed applicant for Infinix, INFX-8000V, V6.35?

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, INFX-8000V, V6.35?

The FDA product code for Infinix, INFX-8000V, V6.35 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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