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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 the device name listed in this FDA 510(k) record. The listed applicant is Wellvii, Inc.. It received FDA 510(k) clearance on 2024-02-02 under 510(k) 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. The listed applicant is Wellvii, Inc.. The 510(k) number is K231625.

When did VitalDetect receive FDA 510(k) clearance?

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

Who is the listed applicant for VitalDetect?

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

What is the FDA product code for VitalDetect?

The FDA product code for VitalDetect is FLL.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Wellvii, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: FLL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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