Medical Device Manufacturer · US , Boston , MA

Etiometry, Inc. - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 2015
10
Total
10
Cleared
0
Denied

Etiometry, Inc. has 10 FDA 510(k) cleared cardiovascular devices. Based in Boston, US.

Latest FDA clearance: Feb 2025. Active since 2015.

Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.

10 devices
1–10 of 10
Etiometry Platform (DAV 5.4 RAE 9.2)
K241479 · PPW Adjunctive Cardiovascular Status Indicator · Cardiovascular
Feb 2025 264d
T3 Platform software
K223578 · PPW Adjunctive Cardiovascular Status Indicator · Cardiovascular
Jul 2023 219d
T3 Platform software
K213423 · PLB Multivariate Vital Signs Index · Cardiovascular
Jan 2023 443d
T3 Platform Software
K213230 · PPW Adjunctive Cardiovascular Status Indicator · Cardiovascular
Jun 2022 266d
T3 Platform software
K202306 · MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · Cardiovascular
Nov 2020 103d
T3 Platform software
K190273 · MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · Cardiovascular
Dec 2019 303d
T3 Software
K163065 · MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · Cardiovascular
May 2017 205d
T3 Software
K152258 · PLB Multivariate Vital Signs Index · Cardiovascular
Mar 2016 233d
T3 Software
K151715 · MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · Cardiovascular
Oct 2015 126d
T3 Software
K142732 · MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · Cardiovascular
Mar 2015 162d
Filters
All10 Cardiovascular 10