Operio— 510(k) K153498

Substantially Equivalent

Toul Meditech AB

FDA 510(k) clearance K153498 for Operio, Substantially Equivalent on 2016-07-20. Applicant: Toul Meditech AB. Device class: 2.

Clearance details

Applicant: Toul Meditech AB
Product code: Code ORC
Device class: Class 2
Regulation: 21 CFR 878.5070
Advisory panel: General, Plastic Surgery
Date received: 2015-12-07
Decision date: 2016-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Västerås, SE

Download summary PDF View on FDA.gov ↗

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