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FDA 510(k)

VitalDetect

K-Number: K231625 · 2024-02-02

ApplicantWellvii, Inc.
Decision Date2024-02-02
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VitalDetect is a medical device manufactured by Wellvii, Inc.. It received FDA 510(k) clearance on 2024-02-02 under approval number K231625. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VitalDetect?

VitalDetect is a medical device that received FDA 510(k) clearance on 2024-02-02. It is manufactured by Wellvii, Inc.. The 510(k) number is K231625.

When was VitalDetect approved by the FDA?

VitalDetect received FDA 510(k) clearance on 2024-02-02, under approval number K231625.

What company makes VitalDetect?

VitalDetect is manufactured by Wellvii, Inc..

What is the FDA product code for VitalDetect?

The FDA product code for VitalDetect is FLL.

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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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