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510(k) K072353

PORTABLE ECSCOPE by Dyansys Corp — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2007
Date Received
August 22, 2007
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 Corp

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  • 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

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  • K252361 — AccurECG Analysis System (v2.0) (December 22, 2025)
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  • 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)