PanopticAI Vital Signs (1.6.1-22)— 510(k) K260066

Name: FDA 510(k) clearance K260066
Creator: U.S. Food and Drug Administration
Published: 2026-05-21

Substantially Equivalent

PanopticAI Technologies Limited

FDA 510(k) clearance K260066 for PanopticAI Vital Signs (1.6.1-22), Substantially Equivalent on 2026-05-21. Applicant: PanopticAI Technologies Limited. Device class: 2.

Clearance details

Applicant: PanopticAI Technologies Limited
Product code: Code QME
Device class: Class 2
Regulation: 21 CFR 870.2785
Advisory panel: Cardiovascular
Date received: 2026-01-09
Decision date: 2026-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hong Kong, HK

Download summary PDF View on FDA.gov ↗

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