FDA Registration
Active
🇺🇸 United States
DELTAWAVE Nasal Pillows System
Reg #: 3022159083
·
FEI: 3022159083
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- REMSLEEP HOLDINGS INC
- Registration Number
- 3022159083
- FEI Number
- 3022159083
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 14175 ICOT Blvd Suite 300
- City
- Clearwater
- State
- FL
- ZIP
- 33760
- Country
- US
Regulatory Submissions
- 510(k) Number
- K233415
Owner / Operator
- Firm Name
- Remsleep Holdings Inc
- Operator Number
- 10084751
- Address
- 14175 ICOT Blvd Suite 300
- City
- Clearwater
- State
- FL
- Postal Code
- 33760
- Country
- US
- Correspondent
- TOM WOOD
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ventilator, Non-Continuous (Respirator) | BZD | Class 2 | Anesthesiology | No | 2025-04-10 |
Proprietary Names
DELTAWAVE Nasal Pillows System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility