Applanation Tonometer HT-5000— 510(k) K232143

Substantially Equivalent

Huvitz Co., Ltd.

FDA 510(k) clearance K232143 for Applanation Tonometer HT-5000, Substantially Equivalent on 2023-10-23. Applicant: Huvitz Co., Ltd.. Device class: 2.

Clearance details

Applicant: Huvitz Co., Ltd.
Product code: Code HKY
Device class: Class 2
Regulation: 21 CFR 886.1930
Advisory panel: Ophthalmic
Date received: 2023-07-19
Decision date: 2023-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anyang-Si, KR

Download summary PDF View on FDA.gov ↗

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K073190 — SLIT LAMP2008-01-11

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