FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
LANDLEX, MODEL S403X
K Number: K063196
·
Decision Jan 23, 2007
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
346
Applicant Total
4
Review Days
95
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Basic Information
- Device Name
- LANDLEX, MODEL S403X
- K Number
- K063196
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3800
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Besteam Technology, Inc.
- Date Received
- October 20, 2006
- Decision Date
- January 23, 2007
- 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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