Infrascanner— 510(k) K211617

Substantially Equivalent

Infrascan, Inc.

FDA 510(k) clearance K211617 for Infrascanner, Substantially Equivalent on 2022-02-09. Applicant: Infrascan, Inc.. Device class: 2.

Clearance details

Applicant: Infrascan, Inc.
Product code: Code OPT
Device class: Class 2
Regulation: 21 CFR 882.1935
Advisory panel: Ophthalmic
Date received: 2021-05-26
Decision date: 2022-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Philadelphia, PA, US

Download summary PDF View on FDA.gov ↗

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