Cleared Traditional

Airmod

K242798 · Heroic Faith International , Ltd. · Anesthesiology
Feb 2025
Decision
165d
Days
Class 2
Risk

About This 510(k) Submission

K242798 is an FDA 510(k) clearance for the Airmod, a Monitor, Breathing Frequency (Class II — Special Controls, product code BZQ), submitted by Heroic Faith International , Ltd. (Taipei, TW). The FDA issued a Cleared decision on February 28, 2025, 165 days after receiving the submission on September 16, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number K242798 FDA.gov
FDA Decision Cleared SESE
Date Received September 16, 2024
Decision Date February 28, 2025
Days to Decision 165 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZQ — Monitor, Breathing Frequency
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.2375

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