FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VTS1000
K Number: K101838
·
Decision Feb 18, 2011
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
5
Applicant Total
1
Review Days
232
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Basic Information
- Device Name
- VTS1000
- K Number
- K101838
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6970
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vuetek Scientific, LLC
- Date Received
- July 1, 2010
- Decision Date
- February 18, 2011
- Product Code
- KZA
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KZA | Device, Vein Location, Liquid Crystal | FDA class 1 | General Hospital |
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