Cleared Traditional

Sotair Device

K212905 · Safe Bvm Corporation · Anesthesiology
Aug 2022
Decision
339d
Days
Class 2
Risk

About This 510(k) Submission

K212905 is an FDA 510(k) clearance for the Sotair Device, a Ventilator, Emergency, Manual (resuscitator) (Class II — Special Controls, product code BTM), submitted by Safe Bvm Corporation (Chesterfield, US). The FDA issued a Cleared decision on August 18, 2022, 339 days after receiving the submission on September 13, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5915.

Submission Details

510(k) Number K212905 FDA.gov
FDA Decision Cleared SESE
Date Received September 13, 2021
Decision Date August 18, 2022
Days to Decision 339 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BTM — Ventilator, Emergency, Manual (resuscitator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5915

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