PS SERIES— 510(k) K061622

Name: FDA 510(k) clearance K061622
Creator: U.S. Food and Drug Administration
Published: 2007-03-05

Substantially Equivalent

Photonic Optische Gerate Gesmbh & Cokg

FDA 510(k) clearance K061622 for PS SERIES, Substantially Equivalent on 2007-03-05. Applicant: Photonic Optische Gerate Gesmbh & Cokg. Device class: 2.

Clearance details

Applicant: Photonic Optische Gerate Gesmbh & Cokg
Product code: Code FFS
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2006-06-12
Decision date: 2007-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vienna, AT

Download summary PDF View on FDA.gov ↗

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