SONOTT FLOWLAB(R)— 510(k) K111730

Substantially Equivalent

Em-Tec GmbH

FDA 510(k) clearance K111730 for SONOTT FLOWLAB(R), Substantially Equivalent on 2012-01-06. Applicant: Em-Tec GmbH. Device class: 2.

Clearance details

Applicant: Em-Tec GmbH
Product code: Code DPW
Device class: Class 2
Regulation: 21 CFR 870.2100
Advisory panel: Cardiovascular
Date received: 2011-06-20
Decision date: 2012-01-06
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Finning, Bavaria, DE

Download summary PDF View on FDA.gov ↗

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