FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇳 India
UL UHD-Clear View 4K Camera System (UL-3Chip 4K)
K Number: K250462
·
Decision Aug 11, 2025
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
97
Applicant Total
1
Review Days
174
Basic Information
- Device Name
- UL UHD-Clear View 4K Camera System (UL-3Chip 4K)
- K Number
- K250462
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Univlabs Technologies Private Limited
- Date Received
- February 18, 2025
- Decision Date
- August 11, 2025
- Product Code
- FET
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FDA class 2 | Gastroenterology, Urology |
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