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FDA 510(k)

Alphenix, INFX-8000V/B, /S, V9.1

K-Number: K203551 · 2020-12-18

ApplicantCanon Medical Systems Corporation
Decision Date2020-12-18
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Alphenix, INFX-8000V/B, /S, V9.1 is a medical device manufactured by Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2020-12-18 under approval number K203551. 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 Alphenix, INFX-8000V/B, /S, V9.1?

Alphenix, INFX-8000V/B, /S, V9.1 is a medical device that received FDA 510(k) clearance on 2020-12-18. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K203551.

When was Alphenix, INFX-8000V/B, /S, V9.1 approved by the FDA?

Alphenix, INFX-8000V/B, /S, V9.1 received FDA 510(k) clearance on 2020-12-18, under approval number K203551.

What company makes Alphenix, INFX-8000V/B, /S, V9.1?

Alphenix, INFX-8000V/B, /S, V9.1 is manufactured by Canon Medical Systems Corporation.

What is the FDA product code for Alphenix, INFX-8000V/B, /S, V9.1?

The FDA product code for Alphenix, INFX-8000V/B, /S, V9.1 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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