FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LINVATEC 300W XENON LIGHT SOURCE
K Number: K031994
·
Decision Aug 21, 2003
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
46
Applicant Total
93
Review Days
55
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Basic Information
- Device Name
- LINVATEC 300W XENON LIGHT SOURCE
- K Number
- K031994
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Linvatec Corp.
- Date Received
- June 27, 2003
- Decision Date
- August 21, 2003
- Product Code
- GCT
- 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 |
|---|---|---|---|
| GCT | Light Source, Endoscope, Xenon Arc | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GCT), ordered by most recent decision date.
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ENDOSCOPIC LIGHT SOURCE XL180/L3
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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