FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TERASON T3200 ULTRASOUND SYSTEM
K Number: K110020
·
Decision Jan 20, 2011
Classifications
1
FEI Numbers
398
Registration Numbers
399
Same Product Code
408
Applicant Total
17
Review Days
17
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Basic Information
- Device Name
- TERASON T3200 ULTRASOUND SYSTEM
- K Number
- K110020
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Teratech Corp.
- Date Received
- January 3, 2011
- Decision Date
- January 20, 2011
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ITX), ordered by most recent decision date.
ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)
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FDA 510(k)
FDA Class 2
·Radiology
UltraDrape UGPIV Barrier and Securement (34-15)
FDA 510(k)
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