FDA 510(k)

VitaloJAK Clinic (Model 7100)

Numéro K : K253293 · 2025-12-03

Date de décision2025-12-03

Code produitDSH

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

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

Questions fréquentes

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. The listed applicant is Vitalograph , Ltd.. The 510(k) number is K253293.

When did VitaloJAK Clinic (Model 7100) receive FDA 510(k) clearance?

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

Who is the listed applicant for VitaloJAK Clinic (Model 7100)?

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

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

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

Essais cliniques associés

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Source officielle

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