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510(k) K170828

Cardiac Trigger Monitor by Ivy Biomedical Systems, Inc. — Product Code DRT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2017
Date Received
March 20, 2017
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

Other clearances by Ivy Biomedical Systems, Inc.

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  • K202138 — Cardiac Trigger Monitor (May 14, 2021)
  • K203653 — MRI PPG Patient Cable (March 2, 2021)
  • K192852 — MRI ECG Patient Cable (March 28, 2020)
  • K171778 — MR Wireless Gating System, Model WGS-100 (March 14, 2018)
  • K151781 — Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor (May 27, 2016)
  • K110987 — CARDIAC TRIGGER MONITOR (July 22, 2011)
  • K091787 — MODEL 6000 TWO PARAMETER BEDSIDE MONITOR (October 9, 2009)
  • K091985 — UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE (July 24, 2009)
  • K083854 — CARDIAC TRIGGER, MODEL: CTM300 (February 13, 2009)

Other clearances for product code DRT

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  • K251364 — Sleepiz One+ (2.5) (July 29, 2025)
  • K234003 — The Circadia C200 System (May 30, 2024)
  • K232354 — Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central (March 22, 2024)
  • K231733 — Neteera 130H-Plus Vital Sign Monitoring Sensor (February 9, 2024)
  • K223163 — Sleepiz One+ (August 18, 2023)
  • K212143 — Neteera 130H/131H Vital Sign Monitoring Sensor (September 28, 2022)
  • K202138 — Cardiac Trigger Monitor (May 14, 2021)
  • K202464 — Vital Sign Monitoring Sensor (Model :XK300) (April 26, 2021)