FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA
K Number: K020956
·
Decision May 16, 2002
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
33
Applicant Total
24
Review Days
52
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA
- K Number
- K020956
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Microtek Medical, Inc.
- Date Received
- March 25, 2002
- Decision Date
- May 16, 2002
- Product Code
- MUI
- 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 |
|---|---|---|---|
| MUI | Media, Coupling, Ultrasound | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MUI), ordered by most recent decision date.
Non-Sterile Ultrasound Gel Sterile Ultrasound Gel
FDA 510(k)
FDA Class 2
·Radiology
EdgeFlow Gel Pad
FDA 510(k)
FDA Class 2
·Radiology
Sterile and Non-Sterile Ultrasonic Coupling Agent
FDA 510(k)
FDA Class 2
·Radiology
Non-Sterile Ultrasound Transmission Gels
FDA 510(k)
FDA Class 2
·Radiology
Sterile and Non-Sterile Ultrasound Gels
FDA 510(k)
FDA Class 2
·Radiology
Ultrasound Transmission Gels
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Microtek Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K110358 | VENODYNE V810 | May 5, 2011 | Substantially Equivalent |
| K102971 | FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK | Feb 23, 2011 | Substantially Equivalent |
| K062899 | MICROTEK MEDICAL SURGICAL GOWN/TOGA | Jan 25, 2007 | Substantially Equivalent |
| K060200 | MICROTEK MEDICAL WARMING DRAPE | May 31, 2006 | Substantially Equivalent |
| K050322 | MICROTEK EQUIPMENT DRAPES | May 17, 2005 | Substantially Equivalent |
| K022903 | CHILLBUSTER | Nov 27, 2002 | Substantially Equivalent |
| K011318 | VENODYNE DVT ADVANTAGE PLUS | Oct 25, 2001 | Substantially Equivalent |
| K001802 | VENODYNE DVT ADVANTAGE MODEL 610 | Jan 9, 2001 | Substantially Equivalent |
| K950906 | LESINSKI SURGICAL EAR DRESSING | Jun 22, 1995 | Substantially Equivalent |
| K925610 | FLEXIBLE HYDROXYLAPATITE/SILICONE SOFT CHIN IMPLAN | Nov 18, 1994 | Substantially Equivalent |