Medium-term Adjunctive Predictive Cardiovascular Indicator
Cardiovascular · 21 CFR 870.2210
The adjunctive predictive cardiovascular indicator is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events within a defined medium-term period. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
Recent MDR events
0 adverse event reports on file
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Registered firms
11 firms currently registered for this product code
Supercomal Medical Products, Sdn Bhd
SUNGAI PETANI Kedah, MY
Becton, Dickinson And Company
Irvine, CA, US
Agilemd
Cupertino, CA, US
Benchmark Electronics, Inc.
WINONA, MN, US
Airstrip Technologies, Inc.
SAN ANTONIO, TX, US
Cct Critical Care Technologies, S.r.l. Also Trading As Edwards Lifesciences Ag
HAINA San Cristobal, DO
Implicity
Paris Ile-de-France, FR
510(k) clearances
5 clearances for this product code
- Agilemd, Inc.Jun 21, 2024
K233253 · eCARTv5 Clinical Deterioration Suite (eCART)
- Clew Medical , Ltd.Jan 13, 2024
K233216 · CLEWICU System
- Implicity, Inc.Oct 25, 2023
K230842 · SignalHF (IM008)
- Edwards Lifesciences, LLCJul 26, 2023
K231038 · Global Hypoperfusion Index (GHI) Algorithm
- Clew Medical , Ltd.Jan 9, 2021
K200717 · CLEWICU System (ClewICUServer and ClewICUnitor)