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510(k) K912008

TRU-VIEW MULTI-CHANNEL DISPLAY by General Devices — Product Code DRT

K912008 is an FDA 510(k) premarket notification submitted by General Devices for the device "TRU-VIEW MULTI-CHANNEL DISPLAY". The FDA issued a decision of Substantially Equivalent on October 9, 1991. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. General Devices has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 1991
Date Received
May 6, 1991
Clearance Type
Traditional
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 General Devices

  • K013533 — EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000) (January 18, 2002)
  • K002089 — ROSETTA-LT/ROSETTA-RX (November 21, 2000)
  • K993202 — EIM-107 PREP-CHECK (December 17, 1999)
  • K940009 — GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300 (April 14, 1995)
  • K935839 — GEMSCOM SERIES 5000, (November 10, 1994)
  • K921929 — GEMSCOM SERIES 300 12-LEAD ECG (12-LEAD OPTION) (September 18, 1992)
  • K914889 — GEMSCOM SERIES 3000 (March 4, 1992)
  • K896153 — MODIFIED DR-2C/PMC 100 (January 19, 1990)
  • K862596 — DR-2C (MODIFICATION) (September 26, 1986)
  • K844650 — DR-2C (January 22, 1985)

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