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510(k) K240251

ANNE Chest by Sibel Health, Inc. — Product Code DRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2024
Date Received
January 30, 2024
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 Sibel Health, Inc.

  • K253021 — ANNE Maternal (February 26, 2026)
  • K242842 — ANNE View, Central Hub (January 8, 2025)
  • K240305 — ANNE Limb (May 28, 2024)
  • K223711 — ANNE One (August 10, 2023)

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)
  • K223711 — ANNE One (August 10, 2023)
  • K220526 — HD+12, HD+15 (May 15, 2023)
  • K223073 — Alio (March 17, 2023)
  • K222398 — Care Team Portal (February 6, 2023)