Cleared Traditional

SpiroSphere

K173937 · Eresearchtechnology GmbH · Anesthesiology
Feb 2019
Decision
416d
Days
Class 2
Risk

About This 510(k) Submission

K173937 is an FDA 510(k) clearance for the SpiroSphere, a Calculator, Predicted Values, Pulmonary Function (Class II — Special Controls, product code BTY), submitted by Eresearchtechnology GmbH (Estenfeld, DE). The FDA issued a Cleared decision on February 15, 2019, 416 days after receiving the submission on December 26, 2017. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1890.

Submission Details

510(k) Number K173937 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 2017
Decision Date February 15, 2019
Days to Decision 416 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BTY — Calculator, Predicted Values, Pulmonary Function
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1890

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