Scope ProTech— 510(k) K191011

Substantially Equivalent

Meditech Endoscopy, Ltd.

FDA 510(k) clearance K191011 for Scope ProTech, Substantially Equivalent on 2019-05-07. Applicant: Meditech Endoscopy, Ltd.. Device class: 2.

Clearance details

Applicant: Meditech Endoscopy, Ltd.
Product code: Code OCU
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2019-04-16
Decision date: 2019-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Basildon, GB

Download summary PDF View on FDA.gov ↗

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