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FDA 510(k)

VIO System (V-1000)

K-Number: K232789 · 2023-12-22

ApplicantEnspectra Health, Inc.
Decision Date2023-12-22
Product CodeQZN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VIO System (V-1000) is a medical device manufactured by Enspectra Health, Inc.. It received FDA 510(k) clearance on 2023-12-22 under approval number K232789. The device is classified under product code QZN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIO System (V-1000)?

VIO System (V-1000) is a medical device that received FDA 510(k) clearance on 2023-12-22. It is manufactured by Enspectra Health, Inc.. The 510(k) number is K232789.

When was VIO System (V-1000) approved by the FDA?

VIO System (V-1000) received FDA 510(k) clearance on 2023-12-22, under approval number K232789.

What company makes VIO System (V-1000)?

VIO System (V-1000) is manufactured by Enspectra Health, Inc..

What is the FDA product code for VIO System (V-1000)?

The FDA product code for VIO System (V-1000) is QZN.

Official Source

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