FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULTRAEKOGEL MODELS EK 2000 & EK 2001
K Number: K030889
·
Decision May 23, 2003
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
33
Applicant Total
3
Review Days
63
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Basic Information
- Device Name
- ULTRAEKOGEL MODELS EK 2000 & EK 2001
- K Number
- K030889
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Inmed Ltda.
- Date Received
- March 21, 2003
- Decision Date
- May 23, 2003
- 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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