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510(k) K200690

LifeSignals ECG Remote Monitoring Patch Platform by Lifesignals, Inc. — Product Code DRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2020
Date Received
March 16, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class
Class II
Regulation Number
870.2910
Review Panel
CV
Submission Type

Other clearances by Lifesignals, Inc.

  • K242018 — UbiqVue™ 2A Multi-parameter System (UX2550) (November 12, 2024)
  • K202868 — LifeSignals Multi-Parameter Remote Monitoring Platform (July 21, 2021)

Other clearances for product code DRG

  • K252984 — Perin Health System (PHD80060-2) (January 22, 2026)
  • K252440 — EasyTeleMed (2.0.2) (October 2, 2025)
  • K250259 — TeleRehab Aermos Cardiopulmonary Rehabilitation (June 4, 2025)
  • K243837 — iBSM (May 16, 2025)
  • K242018 — UbiqVue™ 2A Multi-parameter System (UX2550) (November 12, 2024)
  • K241101 — BioButton System (September 26, 2024)
  • K240251 — ANNE Chest (June 3, 2024)
  • K223711 — ANNE One (August 10, 2023)
  • K220526 — HD+12, HD+15 (May 15, 2023)
  • K223073 — Alio (March 17, 2023)