FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VERATHON INC. BLADDERSCAN BVM 9500 ULTRASOUND
K Number: K090214
·
Decision Mar 13, 2009
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
5
Review Days
43
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Basic Information
- Device Name
- VERATHON INC. BLADDERSCAN BVM 9500 ULTRASOUND
- K Number
- K090214
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Verathon Incorporated
- Date Received
- January 29, 2009
- Decision Date
- March 13, 2009
- 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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|---|---|---|---|
| K172356 | BladderScan Prime PLUS System | Sep 15, 2017 | Substantially Equivalent |
| K153101 | BladderScan Prime System | Nov 19, 2015 | Substantially Equivalent |
| K082456 | VERATHON INC. BLADDERSCAN ULTRASOUND SYSTEM, MODEL BVI 9600 | Dec 1, 2008 | Substantially Equivalent |
| K071217 | BLADDERSCAN BVI 9400 ULTRASOUND | May 17, 2007 | Substantially Equivalent |