Home / 510(k) Clearances / K241101

510(k) K241101

BioButton System by Biointellisense, Inc. — Product Code DRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2024
Date Received
April 22, 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 Biointellisense, Inc.

  • K191614 — BioSticker System (December 18, 2019)

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)
  • 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)
  • K222398 — Care Team Portal (February 6, 2023)