Home / 510(k) Clearances / K222017

510(k) K222017

Biotres by Biotricity — Product Code MWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2022
Date Received
July 8, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph, Ambulatory (Without Analysis)
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type

Other clearances by Biotricity

  • K211709 — Biotres (January 19, 2022)
  • K201040 — Bioflux Software II (July 29, 2020)
  • K172311 — BioFlux Device (December 15, 2017)
  • K162571 — Bioflux Software (October 13, 2016)

Other clearances for product code MWJ

  • K231424 — HeartBeam AIMIGo(TM) System (December 13, 2024)
  • K233864 — ASSURE Wearable ECG (May 7, 2024)
  • K212317 — Eclipse MINI Model 98900 (November 7, 2022)
  • K210758 — Q Patch (June 2, 2022)
  • K211709 — Biotres (January 19, 2022)
  • K211651 — Eclipse PRO (November 22, 2021)
  • K173156 — Integrated CardioRespiratory System (June 8, 2018)
  • K161062 — NR Recorder (June 13, 2016)
  • K152626 — H3+ Holter Recorder (February 26, 2016)
  • K142424 — DR300 HOLTER MONITOR (November 25, 2014)