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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 the device name listed in this FDA 510(k) record. The listed applicant is Enspectra Health, Inc.. It received FDA 510(k) clearance on 2023-12-22 under 510(k) 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. The listed applicant is Enspectra Health, Inc.. The 510(k) number is K232789.

When did VIO System (V-1000) receive FDA 510(k) clearance?

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

Who is the listed applicant for VIO System (V-1000)?

The FDA 510(k) record lists Enspectra Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

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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