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510(k) K191000

Carnation Ambulatory Monitor by Bardy Diagnostics, Inc. — Product Code DSH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2019
Date Received
April 16, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Bardy Diagnostics, Inc.

  • K233110 — Carnation Ambulatory Monitor (November 22, 2023)
  • K210036 — Carnation Ambulatory Monitor (CAM) (February 5, 2021)
  • K200870 — Carnation Ambulatory Monitor (May 1, 2020)
  • K192556 — Carnation Ambulatory Monitor (October 17, 2019)
  • K191471 — Carnation Ambulatory Monitor (August 30, 2019)
  • K143067 — Carnation Ambulatory Monitor (December 22, 2014)

Other clearances for product code DSH

  • K253293 — VitaloJAK Clinic (Model 7100) (December 3, 2025)
  • K243650 — Zio® monitor (DFG0001) (August 15, 2025)
  • K243603 — AeviceMD (May 5, 2025)
  • 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)