FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES
K Number: K140930
·
Decision Jun 9, 2014
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
73
Applicant Total
2
Review Days
59
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Basic Information
- Device Name
- VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES
- K Number
- K140930
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Convida Healthcare & Systems Corporation
- Date Received
- April 11, 2014
- Decision Date
- June 9, 2014
- Product Code
- FSY
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FSY | Light, Surgical, Ceiling Mounted | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Convida Healthcare & Systems Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K132307 | VIDA LED SURGICAL LIGHTING SYSTEM | Nov 5, 2013 | Substantially Equivalent |