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510(k) K170182

CARDIOVIT FT-1 by Schiller AG — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2017
Date Received
January 23, 2017
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

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  • 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)

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