RETINAL CUBE— 510(k) K973950

Substantially Equivalent

Applied Spectral Imaging , Ltd.

FDA 510(k) clearance K973950 for RETINAL CUBE, Substantially Equivalent on 1997-12-12. Applicant: Applied Spectral Imaging , Ltd.. Device class: 2.

Clearance details

Applicant: Applied Spectral Imaging , Ltd.
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 1997-10-16
Decision date: 1997-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Migdal Ha'Emek, IL

Download summary PDF View on FDA.gov ↗

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