Cleared Traditional

Spirobank Oxi

K230501 · Mir Medical International Research USA · Anesthesiology
Dec 2023
Decision
294d
Days
Class 2
Risk

About This 510(k) Submission

K230501 is an FDA 510(k) clearance for the Spirobank Oxi, a Spirometer, Diagnostic (Class II — Special Controls, product code BZG), submitted by Mir Medical International Research USA (New Berlin, US). The FDA issued a Cleared decision on December 15, 2023, 294 days after receiving the submission on February 24, 2023. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1840.

Submission Details

510(k) Number K230501 FDA.gov
FDA Decision Cleared SESE
Date Received February 24, 2023
Decision Date December 15, 2023
Days to Decision 294 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