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510(k) K162571

Bioflux Software by Biotricity, Inc. — Product Code DSH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 2016
Date Received
September 15, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Recorder, Magnetic Tape, Medical
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type

Other clearances by Biotricity, Inc.

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

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  • K242583 — AT-Patch (ATP-C130/ATP-C70) (May 2, 2025)
  • K232670 — HiCardi+ H100 (September 20, 2024)
  • K233906 — S-Patch (S-Patch ExL) (February 16, 2024)
  • K231104 — ABPMpro (November 27, 2023)
  • K233110 — Carnation Ambulatory Monitor (November 22, 2023)
  • K230184 — Holter ECG and ABP System (September 25, 2023)
  • K231289 — S-Patch Ex Wearable ECG Patch (August 30, 2023)