CLEWICU System— 510(k) K233216

Substantially Equivalent

Clew Medical , Ltd.

FDA 510(k) clearance K233216 for CLEWICU System, Substantially Equivalent on 2024-01-13. Applicant: Clew Medical , Ltd.. Device class: 2.

Clearance details

Applicant: Clew Medical , Ltd.
Product code: Code QNL
Device class: Class 2
Regulation: 21 CFR 870.2210
Advisory panel: Cardiovascular
Date received: 2023-09-28
Decision date: 2024-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Poleg, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code QNL

K233253 — eCARTv5 Clinical Deterioration Suite (eCART)2024-06-21
K230842 — SignalHF (IM008)2023-10-25
K231038 — Global Hypoperfusion Index (GHI) Algorithm2023-07-26
K200717 — CLEWICU System (ClewICUServer and ClewICUnitor)2021-01-09

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