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FDA 510(k)

VitaloJAK Clinic (Model 7100)

K-Number: K253293 · 2025-12-03

ApplicantVitalograph , Ltd.
Decision Date2025-12-03
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VitaloJAK Clinic (Model 7100) is a medical device manufactured by Vitalograph , Ltd.. It received FDA 510(k) clearance on 2025-12-03 under approval number K253293. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VitaloJAK Clinic (Model 7100)?

VitaloJAK Clinic (Model 7100) is a medical device that received FDA 510(k) clearance on 2025-12-03. It is manufactured by Vitalograph , Ltd.. The 510(k) number is K253293.

When was VitaloJAK Clinic (Model 7100) approved by the FDA?

VitaloJAK Clinic (Model 7100) received FDA 510(k) clearance on 2025-12-03, under approval number K253293.

What company makes VitaloJAK Clinic (Model 7100)?

VitaloJAK Clinic (Model 7100) is manufactured by Vitalograph , Ltd..

What is the FDA product code for VitaloJAK Clinic (Model 7100)?

The FDA product code for VitaloJAK Clinic (Model 7100) is DSH.

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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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