FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NOVAPROBE LED LIGHT SOURCE
K Number: K131226
·
Decision Jul 24, 2014
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
30
Applicant Total
1
Review Days
450
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Basic Information
- Device Name
- NOVAPROBE LED LIGHT SOURCE
- K Number
- K131226
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Novaprobe Incorporated
- Date Received
- April 30, 2013
- Decision Date
- July 24, 2014
- Product Code
- FCW
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FCW | Light Source, Fiberoptic, Routine | FDA class 2 | Gastroenterology, Urology |
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