510(k) K242798
K242798 is an FDA 510(k) premarket notification submitted by Heroic Faith International , Ltd. for the device "Airmod". The FDA issued a decision of Substantially Equivalent on February 28, 2025. The device falls under product code BZQ (Monitor, Breathing Frequency), a Class II device regulated under 21 CFR 868.2375. Heroic Faith International , Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 2025
- Date Received
- September 16, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Breathing Frequency
- Device Class
- Class II
- Regulation Number
- 868.2375
- Review Panel
- AN
- Submission Type