EASYONE PRO RESPIRATORY ANALYSIS SYSTEM— 510(k) K091428

Name: FDA 510(k) clearance K091428
Creator: U.S. Food and Drug Administration
Published: 2010-01-27

Substantially Equivalent

Ndd Medizitechnik AG

FDA 510(k) clearance K091428 for EASYONE PRO RESPIRATORY ANALYSIS SYSTEM, Substantially Equivalent on 2010-01-27. Applicant: Ndd Medizitechnik AG. Device class: 2.

Clearance details

Applicant: Ndd Medizitechnik AG
Product code: Code BTY
Device class: Class 2
Regulation: 21 CFR 868.1890
Advisory panel: Anesthesiology
Date received: 2009-05-14
Decision date: 2010-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

Download summary PDF View on FDA.gov ↗

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