RECTOSIGHT RS 300-04— 510(k) K994130

Name: FDA 510(k) clearance K994130
Creator: U.S. Food and Drug Administration
Published: 2000-06-30

Substantially Equivalent

Sightline Technologies , Ltd.

FDA 510(k) clearance K994130 for RECTOSIGHT RS 300-04, Substantially Equivalent on 2000-06-30. Applicant: Sightline Technologies , Ltd.. Device class: 2.

Clearance details

Applicant: Sightline Technologies , Ltd.
Product code: Code FER
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1999-12-07
Decision date: 2000-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ginot, Shomron, IL

Download summary PDF View on FDA.gov ↗

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