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510(k) K926298

520 DISPLAY DRIVER- STATUS I by Vidco, Inc. — Product Code DRT

K926298 is an FDA 510(k) premarket notification submitted by Vidco, Inc. for the device "520 DISPLAY DRIVER- STATUS I". The FDA issued a decision of Substantially Equivalent on May 4, 1994. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. Vidco, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 1994
Date Received
December 14, 1992
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 Vidco, Inc.

  • K972880 — MDP2000 MEDICAL DATA PROCESSOR (October 22, 1997)
  • K934093 — 580CDR DISPLAY DRIVER (August 18, 1994)
  • K932894 — 620CSR DISPLAY DRIVER (June 20, 1994)
  • K926219 — 516YT DISPLAY DRIVER (December 16, 1993)
  • K926162 — 580CD DISPLAY DRIVER (November 8, 1993)
  • K890353 — SMDS460 SURGICAL MONITOR DISPLAY SYSTEM (March 2, 1989)

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