Home / 510(k) Clearances / K912139

510(k) K912139

MODEL 704 by Ivy Biomedical Systems, Inc. — Product Code GWM

K912139 is an FDA 510(k) premarket notification submitted by Ivy Biomedical Systems, Inc. for the device "MODEL 704". The FDA issued a decision of Substantially Equivalent on March 25, 1992. The device falls under product code GWM (Device, Monitoring, Intracranial Pressure), a Class II device regulated under 21 CFR 882.1620. Ivy Biomedical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1992
Date Received
May 14, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Monitoring, Intracranial Pressure
Device Class
Class II
Regulation Number
882.1620
Review Panel
NE
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 GWM

  • K252241 — Pressio 3 Multi-parameter Neuromonitoring System (April 10, 2026)
  • K250285 — NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); (August 29, 2025)
  • K240821 — B4C System - Addition of new sensor model (BcSs-PICNIW-2000) (July 18, 2024)
  • K232890 — CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) (February 4, 2024)
  • K201989 — B4C System (October 8, 2021)
  • K210993 — CereLink ICP Monitor (April 30, 2021)
  • K201118 — Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Ex (May 26, 2020)
  • K200630 — Medtronic External Drainage and Monitoring System, Medtronic External Drainage a (April 9, 2020)
  • K200456 — Becker External Drainage and Monitoring System (March 26, 2020)
  • K182073 — BcSs-PICNI-2000 Sensor (October 17, 2019)

FDA data resources