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FDA 510(k)

DormoTech NLab

K-Number: K242290 · 2025-01-08

ApplicantDormotech Medical, Ltd.
Decision Date2025-01-08
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DormoTech NLab is a medical device manufactured by Dormotech Medical, Ltd.. It received FDA 510(k) clearance on 2025-01-08 under approval number K242290. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DormoTech NLab?

DormoTech NLab is a medical device that received FDA 510(k) clearance on 2025-01-08. It is manufactured by Dormotech Medical, Ltd.. The 510(k) number is K242290.

When was DormoTech NLab approved by the FDA?

DormoTech NLab received FDA 510(k) clearance on 2025-01-08, under approval number K242290.

What company makes DormoTech NLab?

DormoTech NLab is manufactured by Dormotech Medical, Ltd..

What is the FDA product code for DormoTech NLab?

The FDA product code for DormoTech NLab is MNR.

Other Devices by Dormotech Medical, Ltd.

K230148Vlab

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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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