SMART MOTORIZED VIEWER— 510(k) K973965

Substantially Equivalent

Smartlight, Ltd.

FDA 510(k) clearance K973965 for SMART MOTORIZED VIEWER, Substantially Equivalent on 1997-12-12. Applicant: Smartlight, Ltd.. Device class: 1.

Clearance details

Applicant: Smartlight, Ltd.
Product code: Code IXC
Device class: Class 1
Regulation: 21 CFR 892.1890
Advisory panel: Radiology
Date received: 1997-10-17
Decision date: 1997-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nesher, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code IXC

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K973115 — ARRIPRO 35 ST/TV1997-09-02
K970240 — DIFFUSER PANEL1997-03-11
K954998 — LILY DARK VIEWER1996-01-29
K954199 — VOXBOX1995-09-29

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