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 a medical device manufactured by Toshibamedical Systems Corporation. It received FDA 510(k) clearance on 2017-12-14 under approval 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. It is manufactured by Toshibamedical Systems Corporation. The 510(k) number is K172863.
When was Infinix-i, INFX-8000V, V7.0 approved by the FDA?
Infinix-i, INFX-8000V, V7.0 received FDA 510(k) clearance on 2017-12-14, under approval number K172863.
What company makes Infinix-i, INFX-8000V, V7.0?
Infinix-i, INFX-8000V, V7.0 is manufactured by Toshibamedical Systems Corporation.
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.