Home / 510(k) Clearances / K091358

510(k) K091358

ECSCOPE 100 by Dyansys, Inc. — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2009
Date Received
May 8, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Dyansys, Inc.

  • K221425 — Primary Relief (September 13, 2022)
  • K221231 — Drug Relief v1 (June 6, 2022)
  • K220397 — ANSiStim-PP (May 12, 2022)
  • K213188 — Primary Relief (January 31, 2022)
  • K212859 — First Relief (December 20, 2021)
  • K211971 — Drug Relief v1 (November 5, 2021)
  • K202940 — First Relief v1 (December 29, 2020)
  • K173861 — Drug Relief (May 2, 2018)
  • K170391 — ANSiStim-PP (March 9, 2017)
  • K141168 — ANSISTIM (May 15, 2015)

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)