PanopticAI Vital Signs— 510(k) K240890

Name: FDA 510(k) clearance K240890
Creator: U.S. Food and Drug Administration
Published: 2024-12-23

Substantially Equivalent

PanopticAI technologies Limited

FDA 510(k) clearance K240890 for PanopticAI Vital Signs, Substantially Equivalent on 2024-12-23. 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: 2024-04-01
Decision date: 2024-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hong Kong, HK

Download summary PDF View on FDA.gov ↗

Recent devices under product code QME

view all

K254169 — SmartSpectra Vital Signs Monitor 1.02026-06-18
K253650 — Anura Mobile Core SDK (M1)2026-06-11
K260066 — PanopticAI Vital Signs (1.6.1-22)2026-05-21
K251200 — Vital Signs2026-02-02
K243687 — Vital Signs2025-08-27

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