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FDA 510(k)

Vlab

K-Number: K230148 · 2023-10-11

ApplicantDormotech Medical, Ltd.
Decision Date2023-10-11
Product CodeGWL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Vlab is a medical device manufactured by Dormotech Medical, Ltd.. It received FDA 510(k) clearance on 2023-10-11 under approval number K230148. The device is classified under product code GWL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vlab?

Vlab is a medical device that received FDA 510(k) clearance on 2023-10-11. It is manufactured by Dormotech Medical, Ltd.. The 510(k) number is K230148.

When was Vlab approved by the FDA?

Vlab received FDA 510(k) clearance on 2023-10-11, under approval number K230148.

What company makes Vlab?

Vlab is manufactured by Dormotech Medical, Ltd..

What is the FDA product code for Vlab?

The FDA product code for Vlab is GWL.

Other Devices by Dormotech Medical, Ltd.

K242290DormoTech NLab

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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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