FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
K Number: K131213
·
Decision Jun 21, 2013
Classifications
1
FEI Numbers
220
Registration Numbers
220
Same Product Code
1171
Applicant Total
22
Review Days
53
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Basic Information
- Device Name
- DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
- K Number
- K131213
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sonoscape Company Limited
- Date Received
- April 29, 2013
- Decision Date
- June 21, 2013
- Product Code
- IYN
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | FDA class 2 | Radiology |
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FDA 510(k)
FDA Class 2
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Other Clearances by Sonoscape Company Limited
| K Number | Device Name | ||
|---|---|---|---|
| K150045 | S30/S40 Digital Color Doppler Ultraound System | Apr 28, 2015 | Substantially Equivalent |
| K142714 | S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System | Jan 29, 2015 | Substantially Equivalent |
| K142815 | S22 Digital Color Doppler Ultrasound System | Jan 28, 2015 | Substantially Equivalent |
| K142710 | S9 Portable Digital Color Doppler Ultrasound System | Jan 5, 2015 | Substantially Equivalent |
| K142474 | S12 Digital Color Doppler Ultrasound System | Dec 19, 2014 | Substantially Equivalent |
| K131262 | DIGITAL ELECTROCARDIOGRAPHS | Nov 14, 2013 | Substantially Equivalent |
| K132527 | DIGITAL COLOR DOPPLER ULTASOUND SYSTEM | Nov 14, 2013 | Substantially Equivalent |
| K132768 | S8 EXP PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM | Oct 4, 2013 | Substantially Equivalent |
| K130801 | DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM | Jun 14, 2013 | Substantially Equivalent |
| K131088 | PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM | May 24, 2013 | Substantially Equivalent |