FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VESISCAN
K Number: K093485
·
Decision Mar 16, 2010
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
14
Review Days
127
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Basic Information
- Device Name
- VESISCAN
- K Number
- K093485
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Life-Tech, Inc.
- Date Received
- November 9, 2009
- Decision Date
- March 16, 2010
- 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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|---|---|---|---|
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| K093662 | ECHOBRIGHT | Jun 24, 2010 | Substantially Equivalent |
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| K082056 | ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1 | Nov 7, 2008 | Substantially Equivalent |
| K082923 | PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, PLT-100C, PLT-150C | Oct 24, 2008 | Substantially Equivalent |
| K081864 | PROLONG | Sep 25, 2008 | Substantially Equivalent |
| K073187 | PERIPHERAL NERVE BLOCK SUPPORT TRAY | Apr 22, 2008 | Substantially Equivalent |