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510(k) K152043

Diagnostic Station DS20 by Schiller AG — Product Code DPS

K152043 is an FDA 510(k) premarket notification submitted by Schiller AG for the device "Diagnostic Station DS20". The FDA issued a decision of Substantially Equivalent on May 6, 2016. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Schiller AG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2016
Date Received
July 23, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph
Device Class
Class II
Regulation Number
870.2340
Review Panel
CV
Submission Type

Other clearances by Schiller AG

  • K221056 — ARGUS PB-3000 (July 6, 2023)
  • K183425 — CARDIOVIT AT-102 G2 (March 2, 2020)
  • K170182 — CARDIOVIT FT-1 (July 19, 2017)
  • K101619 — WELCH ALLYN 1500 PATIENT MONITOR (November 12, 2010)
  • K063814 — BP-200 PLUS (March 7, 2007)
  • K053207 — ARGUS, MODEL LCM (May 19, 2006)
  • K051368 — BR 102 PLUS BLOOD PRESSURE HOLTER SYSTEM (August 9, 2005)
  • K050686 — CARDIOVIT AT-10PLUS (May 4, 2005)
  • K033738 — MONITORING SYSTEM, MODEL ARGUS PB-2200 (August 24, 2004)
  • K031557 — CARDIOVIT AT-102 (April 14, 2004)

Other clearances for product code DPS

  • K252463 — SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) (July 2, 2026)
  • K251670 — MAC 7 Resting ECG Analysis System (January 26, 2026)
  • K252361 — AccurECG Analysis System (v2.0) (December 22, 2025)
  • K252474 — Withings BeamO (SCT02) (November 10, 2025)
  • K250569 — Cardiologs Holter Platform (August 6, 2025)
  • K243252 — ZBPro Diagnostic (July 10, 2025)
  • K243305 — Masimo W1 (April 3, 2025)
  • K241217 — CloudHRV™ System (100-01-001) (January 16, 2025)
  • K241556 — Cardiac Workstation (5000); Cardiac Workstation (7000) (December 17, 2024)
  • K240229 — Masimo W1 (August 8, 2024)

FDA data resources