INFRA-EYE 160— 510(k) K841271

Substantially Equivalent

Fujitsu , Ltd.

FDA 510(k) clearance K841271 for INFRA-EYE 160, Substantially Equivalent on 1984-07-28. Applicant: Fujitsu , Ltd.. Device class: 1.

Clearance details

Applicant: Fujitsu , Ltd.
Product code: Code LHQ
Device class: Class 1
Regulation: 21 CFR 884.2980
Advisory panel: Obstetrics/Gynecology
Date received: 1984-03-27
Decision date: 1984-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.