Home / 510(k) Clearances / K201162

510(k) K201162

Essence 55SP Large Monitor System by Shenyang Torch-Bigtide Digital Technology Co., Ltd. — Product Code DXJ

K201162 is an FDA 510(k) premarket notification submitted by Shenyang Torch-Bigtide Digital Technology Co., Ltd. for the device "Essence 55SP Large Monitor System". The FDA issued a decision of Substantially Equivalent on August 27, 2020. The device falls under product code DXJ (Display, Cathode-Ray Tube, Medical), a Class II device regulated under 21 CFR 870.2450. Shenyang Torch-Bigtide Digital Technology Co., Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2020
Date Received
April 30, 2020
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 Shenyang Torch-Bigtide Digital Technology Co., Ltd.

  • K172969 — Essence 55S Large Monitor System (January 26, 2018)

Other clearances for product code DXJ

  • K212003 — ESSENZ Patient Monitor (November 10, 2021)
  • K212208 — Philips IntelliVue GuardianSoftware (Rev. E.0X) (September 30, 2021)
  • 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)
  • K161767 — Philips IntelliVue GuardianSoftware (January 27, 2017)

FDA data resources