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510(k) K231104

ABPMpro by Somnomedics GmbH — Product Code DSH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 2023
Date Received
April 19, 2023
Clearance Type
Traditional
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

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  • K081485 — SOMNOWATCH (September 18, 2008)
  • K071556 — SOMNOSCREEN EEG10-20 (July 18, 2007)

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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)
  • 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)
  • K223382 — AeviceMD (July 7, 2023)