FDA Registration
Active
🇺🇸 United States
remede® System
Reg #: 3009144177
·
FEI: 3009144177
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- RESPICARDIA, INC.
- Registration Number
- 3009144177
- FEI Number
- 3009144177
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 12400 Whitewater Dr Ste 150
- City
- Minnetonka
- State
- MN
- ZIP
- 55343
- Country
- US
Regulatory Submissions
- PMA Number
- P160039
Owner / Operator
- Firm Name
- Respicardia, Inc.
- Operator Number
- 10046158
- Address
- 12400 Whitewater Drive, Suite 150
- City
- Minnetonka
- State
- MN
- Postal Code
- 55343
- Country
- US
- Correspondent
- Kevin Bentley
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Implanted Phrenic Nerve Stimulator For Central Sleep Apnea | PSR | Class 3 | Unknown | No | 2017-11-09 |
Proprietary Names
remede® System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device