FDA Registration
Active
🇺🇸 United States
Remote Electronic Stethoscope Platform (RESP)
Reg #: 3007236648
·
FEI: 3007236648
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ABV ELECTRONICS, INC DBA SIENNA CORPORATION
- Registration Number
- 3007236648
- FEI Number
- 3007236648
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 475 Horizon Dr
- City
- Suwanee
- State
- GA
- ZIP
- 30024
- Country
- US
Regulatory Submissions
- 510(k) Number
- K201077
Owner / Operator
- Firm Name
- ABV ELECTRONICS, INC dba Sienna Corporation
- Operator Number
- 10044133
- Address
- 475 Horizon Drive
- City
- Suwanee
- State
- GA
- Postal Code
- 30024
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Recorder, Magnetic Tape, Medical | DSH | Class 2 | Cardiovascular | No | 2021-03-10 |
Proprietary Names
Remote Electronic Stethoscope Platform (RESP)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)