LOW FLUID ALARM— 510(k) K080704

Substantially Equivalent

Em-Tec GmbH

FDA 510(k) clearance K080704 for LOW FLUID ALARM, Substantially Equivalent on 2008-04-17. Applicant: Em-Tec GmbH. Device class: 2.

Clearance details

Applicant: Em-Tec GmbH
Product code: Code FLN
Device class: Class 2
Regulation: 21 CFR 880.2420
Advisory panel: General Hospital
Date received: 2008-03-12
Decision date: 2008-04-17
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.