FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SOUNMED SD-2000 PLUS PORTABLE ULTRASOUND SCANNER
K Number: K071156
·
Decision Jul 3, 2007
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
2
Review Days
69
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Basic Information
- Device Name
- SOUNMED SD-2000 PLUS PORTABLE ULTRASOUND SCANNER
- K Number
- K071156
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sounmed, Inc.
- Date Received
- April 25, 2007
- Decision Date
- July 3, 2007
- Product Code
- IYO
- 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | FDA class 2 | Radiology |
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Other Clearances by Sounmed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K070845 | SOUNMED COLOPOSCOPE COLPO-99/99PLUS | Oct 12, 2007 | Substantially Equivalent |