FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM
K Number: K093713
·
Decision Jan 19, 2010
Classifications
1
FEI Numbers
398
Registration Numbers
399
Same Product Code
408
Applicant Total
1
Review Days
49
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Basic Information
- Device Name
- ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM
- K Number
- K093713
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Civco Medical Instruments
- Date Received
- December 1, 2009
- Decision Date
- January 19, 2010
- Product Code
- ITX
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | FDA class 2 | Radiology |
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