RECTOSIGHT RS300-04; AND PROTOSIGHT PS300-04 DEVICE— 510(k) K011825

Name: FDA 510(k) clearance K011825
Creator: U.S. Food and Drug Administration
Published: 2001-07-11

Substantially Equivalent

Sightline Technologies , Ltd.

FDA 510(k) clearance K011825 for RECTOSIGHT RS300-04; AND PROTOSIGHT PS300-04 DEVICE, Substantially Equivalent on 2001-07-11. Applicant: Sightline Technologies , Ltd.. Device class: 2.

Clearance details

Device name as filed: RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE
Applicant: Sightline Technologies , Ltd.
Product code: Code FER
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2001-06-11
Decision date: 2001-07-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Matam, Haifa, IL

Download summary PDF View on FDA.gov ↗

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