SpiroSphere— 510(k) K173937

Substantially Equivalent

Eresearchtechnology GmbH

FDA 510(k) clearance K173937 for SpiroSphere, Substantially Equivalent on 2019-02-15. Applicant: Eresearchtechnology GmbH.

Clearance details

Applicant: Eresearchtechnology GmbH
Product code: Code BTY
Advisory panel: Anesthesiology
Date received: 2017-12-26
Decision date: 2019-02-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Estenfeld, DE

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