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FDA 510(k)

INFX-8000V WITH

K-Number: K120073 · 2012-01-26

ApplicantToshibamedical Systems Corporation
Decision Date2012-01-26
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INFX-8000V WITH 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 2012-01-26 under 510(k) number K120073. 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 INFX-8000V WITH?

INFX-8000V WITH is a medical device that received FDA 510(k) clearance on 2012-01-26. The listed applicant is Toshibamedical Systems Corporation. The 510(k) number is K120073.

When did INFX-8000V WITH receive FDA 510(k) clearance?

INFX-8000V WITH received FDA 510(k) clearance on 2012-01-26, under 510(k) number K120073.

Who is the listed applicant for INFX-8000V WITH?

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 INFX-8000V WITH?

The FDA product code for INFX-8000V WITH is OWB.

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Related Devices (Code: 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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