Home / 510(k) Clearances / K191314

510(k) K191314

Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q by Chongqing Sunkingdom Medical Instrument Co., Ltd. — Product Code HKY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2019
Date Received
May 15, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tonometer, Manual
Device Class
Class II
Regulation Number
886.1930
Review Panel
OP
Submission Type

Other clearances by Chongqing Sunkingdom Medical Instrument Co., Ltd.

  • K222787 — Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3 (January 9, 2023)
  • K182306 — Sunkingdom Slit Lamp (November 22, 2018)

Other clearances for product code HKY

  • K241447 — iCare ST500 (TA04) (September 27, 2024)
  • K233516 — Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318) (May 1, 2024)
  • K234037 — CATS-L Tonometer™ Prism (February 9, 2024)
  • K232143 — Applanation Tonometer HT-5000 (October 23, 2023)
  • K220852 — iCare IC200 (October 6, 2022)
  • K211355 — iCare HOME2 (January 25, 2022)
  • K203850 — CATS®-D Tonometer Prism (June 14, 2021)
  • K200966 — Icare HOME Tonometer (May 7, 2020)
  • K190316 — Icare ic200 (January 14, 2020)
  • K182491 — Applanation tonometer AT-2 (December 10, 2018)