FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUNPEX TECHNOLOGIES MODEL SE03
K Number: K033019
·
Decision Jan 22, 2004
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
346
Applicant Total
4
Review Days
118
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Basic Information
- Device Name
- SUNPEX TECHNOLOGIES MODEL SE03
- K Number
- K033019
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 890.3800
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sunpex Technology Co., Ltd.
- Date Received
- September 26, 2003
- Decision Date
- January 22, 2004
- Product Code
- INI
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| INI | Vehicle, Motorized 3-Wheeled | FDA class 2 | Physical Medicine |
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