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

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.

Clearance details

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

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