RESPIFIT S, MODEL RS-LR1001004— 510(k) K080299

Name: FDA 510(k) clearance K080299
Creator: U.S. Food and Drug Administration
Published: 2009-01-13

Substantially Equivalent

Eumedics Medizintechnik Und Marketing GmbH

FDA 510(k) clearance K080299 for RESPIFIT S, MODEL RS-LR1001004, Substantially Equivalent on 2009-01-13. Applicant: Eumedics Medizintechnik Und Marketing GmbH. Device class: 2.

Clearance details

Applicant: Eumedics Medizintechnik Und Marketing GmbH
Product code: Code BWF
Device class: Class 2
Regulation: 21 CFR 868.5690
Advisory panel: Anesthesiology
Date received: 2008-02-05
Decision date: 2009-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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