510(k) K252078
K252078 is an FDA 510(k) premarket notification submitted by Compal Electronics, Inc. for the device "BreathePal Bilevel (GFM50-MD2201)". The FDA issued a decision of Substantially Equivalent on March 17, 2026. The device falls under product code MNS (Ventilator, Continuous, Non-Life-Supporting), a Class II device regulated under 21 CFR 868.5895. Compal Electronics, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 2026
- Date Received
- July 2, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator, Continuous, Non-Life-Supporting
- Device Class
- Class II
- Regulation Number
- 868.5895
- Review Panel
- AN
- Submission Type