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510(k) K890353

SMDS460 SURGICAL MONITOR DISPLAY SYSTEM by Vidco, Inc. — Product Code DXJ

K890353 is an FDA 510(k) premarket notification submitted by Vidco, Inc. for the device "SMDS460 SURGICAL MONITOR DISPLAY SYSTEM". The FDA issued a decision of Substantially Equivalent on March 2, 1989. The device falls under product code DXJ (Display, Cathode-Ray Tube, Medical), a Class II device regulated under 21 CFR 870.2450. Vidco, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1989
Date Received
January 24, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Display, Cathode-Ray Tube, Medical
Device Class
Class II
Regulation Number
870.2450
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)
  • K926298 — 520 DISPLAY DRIVER- STATUS I (May 4, 1994)
  • K926219 — 516YT DISPLAY DRIVER (December 16, 1993)
  • K926162 — 580CD DISPLAY DRIVER (November 8, 1993)

Other clearances for product code DXJ

  • K212003 — ESSENZ Patient Monitor (November 10, 2021)
  • K212208 — Philips IntelliVue GuardianSoftware (Rev. E.0X) (September 30, 2021)
  • K201162 — Essence 55SP Large Monitor System (August 27, 2020)
  • K173107 — Vios Central Station Monitor Software, Vios Central Server Software (July 26, 2018)
  • K180534 — Philips IntelliVue GuardianSoftware (July 16, 2018)
  • K173381 — Nexxis OR (February 22, 2018)
  • K172969 — Essence 55S Large Monitor System (January 26, 2018)
  • K170460 — Sorin Connect (June 8, 2017)
  • K170537 — Nexxis OR, Nexxis (April 21, 2017)
  • K161880 — NIVR58-T kit (March 14, 2017)

FDA data resources