FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
XENON LIGHTSOURCE
K Number: K962365
·
Decision Jul 18, 1996
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
46
Applicant Total
3
Review Days
29
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Basic Information
- Device Name
- XENON LIGHTSOURCE
- K Number
- K962365
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dsp Worldwide
- Date Received
- June 19, 1996
- Decision Date
- July 18, 1996
- 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 |
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