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510(k) K023616

PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES) by Ivy Biomedical Systems, Inc. — Product Code DRT

K023616 is an FDA 510(k) premarket notification submitted by Ivy Biomedical Systems, Inc. for the device "PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES)". The FDA issued a decision of Substantially Equivalent on November 4, 2002. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. Ivy Biomedical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2002
Date Received
October 29, 2002
Clearance Type
Special
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.

  • K240087 — RT Carbon ECG Leads (September 13, 2024)
  • 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)
  • K170828 — Cardiac Trigger Monitor (May 17, 2017)
  • 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)

Other clearances for product code DRT

  • K261286 — The Circadia C300 System (C300) (May 20, 2026)
  • K252676 — The Circadia C300 System (C300) (February 3, 2026)
  • K253388 — Sleepiz One+ (Model 2.5) (January 28, 2026)
  • 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)

FDA data resources