eCARTv5 Clinical Deterioration Suite (eCART)— 510(k) K233253

Name: FDA 510(k) clearance K233253
Creator: U.S. Food and Drug Administration
Published: 2024-06-21

Substantially Equivalent

Agilemd, Inc.

FDA 510(k) clearance K233253 for eCARTv5 Clinical Deterioration Suite (eCART), Substantially Equivalent on 2024-06-21. Applicant: Agilemd, Inc.. Device class: 2.

Clearance details

Applicant: Agilemd, Inc.
Product code: Code QNL
Device class: Class 2
Regulation: 21 CFR 870.2210
Advisory panel: Cardiovascular
Date received: 2023-09-28
Decision date: 2024-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QNL

view all

K233216 — CLEWICU System2024-01-13
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.