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510(k) K150289

CARDIOLINE HD+ by Cardioline S.P.A — Product Code DRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2015
Date Received
February 5, 2015
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 Cardioline S.P.A

  • K220526 — HD+12, HD+15 (May 15, 2023)
  • K160746 — CARDIOLINE touchECG (November 2, 2016)
  • K160840 — ECG100+, ECG200+ (August 12, 2016)

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)