Cleared Traditional

Spirotrac

K201562 · Vitalograph (Ireland) , Ltd. · Anesthesiology
Oct 2020
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K201562 is an FDA 510(k) clearance for the Spirotrac, a Spirometer, Diagnostic (Class II — Special Controls, product code BZG), submitted by Vitalograph (Ireland) , Ltd. (Ennis Co Clare, IE). The FDA issued a Cleared decision on October 14, 2020, 126 days after receiving the submission on June 10, 2020. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1840.

Submission Details

510(k) Number K201562 FDA.gov
FDA Decision Cleared SESE
Date Received June 10, 2020
Decision Date October 14, 2020
Days to Decision 126 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZG — Spirometer, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1840