FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYN-OPTICS #5200
K Number: K820624
·
Decision Apr 1, 1982
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
97
Applicant Total
1
Review Days
24
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SYN-OPTICS #5200
- K Number
- K820624
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Syn-Optics
- Date Received
- March 8, 1982
- Decision Date
- April 1, 1982
- Product Code
- FET
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- RA
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FET), ordered by most recent decision date.
ProVee Video Processing Unit (PV-003)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UL UHD-Clear View 4K Camera System (UL-3Chip 4K)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Endoscopic Camera System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Endoscopic Video Image Processor (RP-IPD-V1000F)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology