EasyOne Air Spirometer— 510(k) K161536

Substantially Equivalent

Ndd Medizintechnik AG

FDA 510(k) clearance K161536 for EasyOne Air Spirometer, Substantially Equivalent on 2017-01-05. Applicant: Ndd Medizintechnik AG. Device class: 2.

Clearance details

Applicant: Ndd Medizintechnik AG
Product code: Code BZG
Device class: Class 2
Regulation: 21 CFR 868.1840
Advisory panel: Anesthesiology
Date received: 2016-06-03
Decision date: 2017-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zurich, CH

Download summary PDF View on FDA.gov ↗

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