Vlab— 510(k) K230148

Substantially Equivalent

Dormotech Medical, Ltd.

FDA 510(k) clearance K230148 for Vlab, Substantially Equivalent on 2023-10-11. Applicant: Dormotech Medical, Ltd.. Device class: 2.

Clearance details

Applicant: Dormotech Medical, Ltd.
Product code: Code GWL
Device class: Class 2
Regulation: 21 CFR 882.1835
Advisory panel: Neurology
Date received: 2023-01-19
Decision date: 2023-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Afula, IL

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.