Vital Signs— 510(k) K211906

Substantially Equivalent

Oxehealth Limited

FDA 510(k) clearance K211906 for Vital Signs, Substantially Equivalent on 2021-07-20. Applicant: Oxehealth Limited. Device class: 2.

Clearance details

Applicant: Oxehealth Limited
Product code: Code QME
Device class: Class 2
Regulation: 21 CFR 870.2785
Advisory panel: Cardiovascular
Date received: 2021-06-21
Decision date: 2021-07-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Oxford, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code QME

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

More clearances from Oxehealth Limited

K233618 — Oxevision Sleep Device2024-04-03
K220899 — Oxehealth Vital Signs2022-04-29
DEN200019 — Oxehealth Vital Signs2021-03-26

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