ARGOS— 510(k) K150754

Substantially Equivalent

Santec Corporation

FDA 510(k) clearance K150754 for ARGOS, Substantially Equivalent on 2015-10-02. Applicant: Santec Corporation. Device class: 2.

Clearance details

Applicant: Santec Corporation
Product code: Code MXK
Device class: Class 2
Regulation: 21 CFR 886.1850
Advisory panel: Ophthalmic
Date received: 2015-03-23
Decision date: 2015-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Komaki, JP

Download summary PDF View on FDA.gov ↗

Recent devices under product code MXK

K251848 — Pentacam® Cornea OCT2026-03-13
K252348 — Tomey Optical Biometer OA-2000 (OA-2000)2025-12-18
K223700 — BOSS2024-08-16
K222933 — MYAH2023-06-29
K211868 — MYAH2022-03-01

More clearances from Santec Corporation

K191051 — ARGOS2019-05-16

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