FDA 510(k) Applications Submitted by Rich Laguna
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K131046 |
04/15/2013 |
VASCULAIRE COMPRESSION SYSTEM, VASCULAIRE SLEEVE (FOOT & CALF), VASCULAIRE SLEEVE (CALF) |
VENOUS HEALTH SYSTEMS, INC. |
K181502 |
06/07/2018 |
Zio AT ECG Monitoring System, ZEUS System |
iRhythm Technologies, Inc. |
K202359 |
08/19/2020 |
Zio Monitor |
iRhythm Technologies, Inc. |
K122609 |
08/27/2012 |
VASCULAIRE COMPRESSION SYSTEM MODEL FLS-0003; VASCULAIRE SLEEVE (FOOT & CALF) MODEL FLS-0002; VASCULAIRE SLEEVE (CALF) F |
VENOUS HEALTH SYSTEMS, INC. |
K142681 |
09/19/2014 |
ZEUS (ZIO ECG Utilization Service) System |
iRhythm Technologies, Inc. |
K143513 |
12/11/2014 |
ZIO SR ECG Monitoring Service |
iRhythm Technologies, Inc. |
K163512 |
12/15/2016 |
Zio AT ECG Monitoring System |
IRHYTHM TECHNOLOGIES, INC. |
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