FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNI-PATCH ULTRASOUND COUPLING GEL
K Number: K021132
·
Decision May 15, 2002
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
33
Applicant Total
3
Review Days
36
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Basic Information
- Device Name
- UNI-PATCH ULTRASOUND COUPLING GEL
- K Number
- K021132
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- The Ludlow Company LP
- Date Received
- April 9, 2002
- Decision Date
- May 15, 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 |
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