Applanation tonometer AT-2— 510(k) K182491

Name: FDA 510(k) clearance K182491
Creator: U.S. Food and Drug Administration
Published: 2018-12-10

Substantially Equivalent

Takagi Seiko Co., Ltd.

FDA 510(k) clearance K182491 for Applanation tonometer AT-2, Substantially Equivalent on 2018-12-10. Applicant: Takagi Seiko Co., Ltd.. Device class: 2.

Clearance details

Applicant: Takagi Seiko Co., Ltd.
Product code: Code HKY
Device class: Class 2
Regulation: 21 CFR 886.1930
Advisory panel: Ophthalmic
Date received: 2018-09-11
Decision date: 2018-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nakano-Shi, JP

Download summary PDF View on FDA.gov ↗

Recent devices under product code HKY

view all

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 Takagi Seiko Co., Ltd.

view all

K172728 — Applanation tonometer AT-12017-10-17
K162636 — Marco Ultra M3, Marco Ultra M42017-04-14
K152535 — Z5 Slit lamp microscope, Z2 Slit lamp microscope2016-05-26
K063352 — ELLEX SLIT LAMP, MODEL 30XL2007-03-13

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