FDA Registration
Active
🇺🇸 United States
HandHeld Airway Clearance Device
Reg #: 3024841249
·
FEI: 3024841249
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BETTER BREATHING DEVICES INC
- Registration Number
- 3024841249
- FEI Number
- 3024841249
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1209 Orange Street
- City
- Wilmington
- State
- DE
- ZIP
- 19801
- Country
- US
Regulatory Submissions
- 510(k) Number
- K203209
Owner / Operator
- Firm Name
- Better Breathing Devices Inc
- Operator Number
- 10087761
- Address
- 1644 Platte St, STE 400
- City
- Denver
- State
- CO
- Postal Code
- 80202
- Country
- US
- Correspondent
- Paul O'Brien
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Percussor, Powered-Electric | BYI | Class 2 | Anesthesiology | No | 2024-04-15 |
Proprietary Names
HandHeld Airway Clearance Device
Powered Precussor
AirPhysio Health and Wellness
AirPhysio with Travel Case
Establishment Types
Complaint File Establishment per 21 CFR 820.198