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510(k) K031557

CARDIOVIT AT-102 by Schiller AG — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2004
Date Received
May 19, 2003
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)
  • K152043 — Diagnostic Station DS20 (May 6, 2016)
  • 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)

Other clearances for product code DPS

  • 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)
  • K232161 — DeepRhythm Platform (June 20, 2024)