FDA 510(k)

Vlab

K-Number: K230148 · 2023-10-11

Decision Date2023-10-11

Product CodeGWL

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Vlab is the device name listed in this FDA 510(k) record. The listed applicant is Dormotech Medical, Ltd.. It received FDA 510(k) clearance on 2023-10-11 under 510(k) 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. The listed applicant is Dormotech Medical, Ltd.. The 510(k) number is K230148.

When did Vlab receive FDA 510(k) clearance?

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

Who is the listed applicant for Vlab?

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

What is the FDA product code for Vlab?

The FDA product code for Vlab is GWL.

Other records listing Dormotech Medical, Ltd. 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.

K242290DormoTech NLab

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.