SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS— 510(k) K991302

Name: FDA 510(k) clearance K991302
Creator: U.S. Food and Drug Administration
Published: 1999-06-01

Substantially Equivalent

Smartlight, Inc.

FDA 510(k) clearance K991302 for SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS, Substantially Equivalent on 1999-06-01. Applicant: Smartlight, Inc.. Device class: 1.

Clearance details

Applicant: Smartlight, Inc.
Product code: Code IXC
Device class: Class 1
Regulation: 21 CFR 892.1890
Advisory panel: Radiology
Date received: 1999-04-16
Decision date: 1999-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hackensack, NJ, 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.