SpiroScout— 510(k) K160116

Substantially Equivalent

Ganshorn Medizin Electronic GmbH

FDA 510(k) clearance K160116 for SpiroScout, Substantially Equivalent on 2016-10-07. Applicant: Ganshorn Medizin Electronic GmbH.

Clearance details

Applicant: Ganshorn Medizin Electronic GmbH
Product code: Code BZG
Advisory panel: Anesthesiology
Date received: 2016-01-19
Decision date: 2016-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Niederlauer, DE

Download summary PDF View on FDA.gov ↗

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