Adjunctive Cardiovascular Status Indicator
Cardiovascular · 21 CFR 870.2200
The adjunctive cardiovascular status indicator is a prescription device based on sensor technology for the measurement of a physical parameter(s). 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
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
5 firms currently registered for this product code
510(k) clearances
8 clearances for this product code
- Etiometry, Inc.Apr 3, 2026
K254066 · Etiometry Platform
- Prolaio, Inc.Dec 16, 2025
K252204 · prolaio eVO2peak Module (Version 1.0)
- Etiometry, Inc.Feb 12, 2025
K241479 · Etiometry Platform (DAV 5.4 RAE 9.2)
- Etiometry, Inc.Jul 7, 2023
K223578 · T3 Platform software
- Etiometry, Inc.Jun 22, 2022
K213230 · T3 Platform Software
- Flashback Technologies, Inc.Jun 17, 2022
K213255 · CipherOx CRI Tablet
- Flashback Technologies, Inc.Jul 24, 2018
K173929 · CipherOx CRI M1
- Flashback Technologies, Inc.Dec 21, 2016
DEN160020 · CipherOx CRI Tablet