FDA Registration
Active
🇺🇸 United States
Kosmos ECG Patient Cable
Reg #: 3013757696
·
FEI: 3013757696
·
Expires 2025
Products
5
Proprietary Names
10
Establishment Types
3
Classifications
5
Registration Details
- Registration Name
- ECHONOUS, INC.
- Registration Number
- 3013757696
- FEI Number
- 3013757696
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 8310 154th Ave NE, Building B, Suite 200
- City
- Redmond
- State
- WA
- ZIP
- 98052
- Country
- US
Regulatory Submissions
- 510(k) Number
- K193518
Owner / Operator
- Firm Name
- ECHONOUS, INC.
- Operator Number
- 10055454
- Address
- 8310 154th Ave NE, Building B, Suite 200
- City
- Redmond
- State
- WA
- Postal Code
- 98052
- Country
- US
- Correspondent
- Joshua Kim
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2020-03-27 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2020-03-27 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2020-03-27 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2020-03-27 |
| Stethoscope, Electronic | DQD | Class 2 | Cardiovascular | No | 2020-03-27 |
Proprietary Names
Kosmos ECG Patient Cable
KOSMOS
Kosmos Platform
Kosmos Torso
Kosmos Binaural Headset
Kosmos Torso-One - USB
Kosmos System
Kosmos Torso-One
Kosmos Bridge
AI Station 2
Establishment Types
Manufacture Medical Device
Remanufacture Medical Device
Complaint File Establishment per 21 CFR 820.198