Devices · Heroic Faith International Ltd.

Airmod

Heroic Faith International Ltd. is listed for Airmod (K242798). The FDA list gives February 28, 2025 as the date of the final decision. The lead panel is Anesthesiology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is BZQ. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K242798

Official FDA database record

Date of final decision

February 28, 2025

Company on the FDA list

Heroic Faith International Ltd.

Lead panel

Anesthesiology

Primary product code

BZQ

openFDA device name for the code

Monitor, Breathing Frequency

Device class

2

Regulation number

868.2375

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary