510(k) K242018

Device
UbiqVue? 2A Multi-parameter System (UX2550)
Applicant
Lifesignals, Inc.
510(k) number
K242018
Product code
DRG
Decision
Substantially Equivalent (SESE)
Decision date
2024-11-12
Date received
2024-07-10
Regulation
870.2910
Classification name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Saravanan Balasubramanian
Address
426 S Hillview Dr. Milpitas CA US 95035 95035

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code DRG

510(k)DeviceApplicantDecision date
K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC2026-01-22
K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.2025-10-02
K250259TeleRehab Aermos Cardiopulmonary RehabilitationThe ScottCare Corporation2025-06-04
K243837iBSMIorbit Digital Technologies Private Limited2025-05-16
K241101BioButton SystemBiointellisense, Inc.2024-09-26
K240251ANNE ChestSibel Health, Inc.2024-06-03
K223711ANNE OneSibel Health, Inc.2023-08-10
K220526HD+12, HD+15Cardioline S.P.A2023-05-15
K223073AlioAlio, Inc.2023-03-17
K222398Care Team PortalVivify Health, Inc.2023-02-06
K212957BioButton SystemBiolntellisense, Inc.2022-12-12
K221530ANNE PediatricSibel, Inc.2022-11-22
K212883ers2 - ergoline Rehabilitation SystemErgoline GmbH2022-07-15
K213233EZYPRO ECG Recorder (Model: UG02)Sigknow Biomedical Co., Ltd.2022-06-23
K211365Alio Medical Remote Monitoring SystemGraftworx, Inc. Dba Alio2022-03-24