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EchoNous Samsung S8 Tablet with Software (Refurbished)
FDA UDIClass II (US FDA UDI)
by EchoNous
Identity
- Trade Name
- EchoNous Samsung S8 Tablet with Software (Refurbished) FDA UDI
- Generic Name
- Hand-held ultrasound imaging system, body-surface FDA UDI
- Device Name
- EchoNous (Uscan) Samsung S8 Tablet with Software (Refurbished) FDA UDI
- Model / Reference
- R007635 FDA UDI
- Description
- EchoNous (Uscan) Samsung S8 Tablet with Software (Refurbished) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09353278000670 FDA UDI
- 510(k) Number
- K160420 FDA UDI
- FDA Product Code
- IYO FDA UDI
- GMDN Term
- Hand-held ultrasound imaging system, body-surface FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hand-held ultrasound imaging system, body-surface
EchoNous Samsung S8 Tablet with Software (Refurbished) by EchoNous — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Hand-held ultrasound imaging system, body-surface.
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- GUI — Sonivate Medical, Inc. · Class II
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- Clarius Ultrasound Scanner — Clarius Mobile Health Corp · Class II
Cleared under the same submission
K160420 also covers:
- EchoNous Samsung S8 Tablet with Software — EchoNous
- Uscan Sector Probe — EchoNous
- Uscan Sector Probe (Japan) — EchoNous
- Uscan Sector Probe - Refurbished — EchoNous
- Uscan Sector Probe - Refurbished (Japan) — EchoNous
- Uscan System — EchoNous
- Uscan System (Japan) — EchoNous
- Uscan System - Refurbished — EchoNous
- Uscan System - Refurbished (Japan) — EchoNous
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- EchoNous
Sources (1)
- FDA UDI f307f1a8-89bd-4512-a2bf-cfa12d47a8d9 34 fields · synced May 30, 2026