FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
BreathePal Bilevel (GFM50-MD2201)
K Number: K252078
·
Decision Mar 17, 2026
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
46
Applicant Total
3
Review Days
258
Basic Information
- Device Name
- BreathePal Bilevel (GFM50-MD2201)
- K Number
- K252078
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5895
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Compal Electronics, Inc.
- Date Received
- July 2, 2025
- Decision Date
- March 17, 2026
- Product Code
- MNS
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MNS | Ventilator, Continuous, Non-Life-Supporting | FDA class 2 | Anesthesiology |
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