FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SONOGEL
K Number: K953468
·
Decision Oct 17, 1995
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
14
Review Days
85
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Basic Information
- Device Name
- SONOGEL
- K Number
- K953468
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sonotech, Inc.
- Date Received
- July 24, 1995
- Decision Date
- October 17, 1995
- 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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| K033178 | ULTRABIO | Aug 4, 2004 | Substantially Equivalent |
| K031222 | SCANLUBE | Jul 23, 2003 | Substantially Equivalent |
| K031894 | SCANTEC PAD | Jul 18, 2003 | Substantially Equivalent |
| K013701 | ENDO-GLIDE | Feb 4, 2002 | Substantially Equivalent |
| K013170 | SCANTAC MEMBRANE OR SCANTAC STRIP | Nov 13, 2001 | Substantially Equivalent |
| K984562 | VIVOSONIC | Jun 8, 1999 | Substantially Equivalent |
| K983691 | SCANFLEX SOLID COUPLANT MEMBRANE | May 5, 1999 | Substantially Equivalent |
| K983985 | HYBRISONIC SHEATH | Feb 25, 1999 | Substantially Equivalent |
| K981028 | ULTRA IMAGE AND ULTRA SCAN | Aug 21, 1998 | Substantially Equivalent |