INFX-8000V, V6.20
K-Number: K152696 · 2016-01-12
ApplicantToshibamedical Systems Corporation
Decision Date2016-01-12
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
INFX-8000V, V6.20 is a medical device manufactured by Toshibamedical Systems Corporation. It received FDA 510(k) clearance on 2016-01-12 under approval number K152696. 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, V6.20?
INFX-8000V, V6.20 is a medical device that received FDA 510(k) clearance on 2016-01-12. It is manufactured by Toshibamedical Systems Corporation. The 510(k) number is K152696.
When was INFX-8000V, V6.20 approved by the FDA?
INFX-8000V, V6.20 received FDA 510(k) clearance on 2016-01-12, under approval number K152696.
What company makes INFX-8000V, V6.20?
INFX-8000V, V6.20 is manufactured by Toshibamedical Systems Corporation.
What is the FDA product code for INFX-8000V, V6.20?
The FDA product code for INFX-8000V, V6.20 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.