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FDA 510(k)

INFX-8000C, V6.20

K-Number: K152697 · 2016-01-15

ApplicantToshibamedical Systems Corporation
Decision Date2016-01-15
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INFX-8000C, V6.20 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 2016-01-15 under 510(k) number K152697. 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-8000C, V6.20?

INFX-8000C, V6.20 is a medical device that received FDA 510(k) clearance on 2016-01-15. The listed applicant is Toshibamedical Systems Corporation. The 510(k) number is K152697.

When did INFX-8000C, V6.20 receive FDA 510(k) clearance?

INFX-8000C, V6.20 received FDA 510(k) clearance on 2016-01-15, under 510(k) number K152697.

Who is the listed applicant for INFX-8000C, V6.20?

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-8000C, V6.20?

The FDA product code for INFX-8000C, V6.20 is OWB.

Other records listing Toshibamedical Systems Corporation as applicant

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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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