Icare HOME Tonometer— 510(k) K200966

Substantially Equivalent

Icare Finland OY

FDA 510(k) clearance K200966 for Icare HOME Tonometer, Substantially Equivalent on 2020-05-07. Applicant: Icare Finland OY. Device class: 2.

Clearance details

Applicant: Icare Finland OY
Product code: Code HKY
Device class: Class 2
Regulation: 21 CFR 886.1930
Advisory panel: Ophthalmic
Date received: 2020-04-10
Decision date: 2020-05-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Vantaa, FI

Download summary PDF View on FDA.gov ↗

Recent devices under product code HKY

K241447 — iCare ST500 (TA04)2024-09-27
K233516 — Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)2024-05-01
K234037 — CATS-L Tonometer Prism2024-02-09
K232143 — Applanation Tonometer HT-50002023-10-23
K220852 — iCare IC2002022-10-06

More clearances from Icare Finland OY

K211355 — iCare HOME22022-01-25
K190316 — Icare ic2002020-01-14
K163343 — Icare HOME tonometer2017-03-21
K153694 — Icare ic1002016-04-19

Data sourced from openFDA. This site is unofficial and independent of the FDA.