FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OLYMPUS TJF-140R/JF-140R EVIS DUODENOVIDEOSCOPES AND ACCESSORIES, OLYMPUS MAJ-311/MAJ-411 DISTAL COVERS
K Number: K980465
·
Decision Apr 21, 1998
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
34
Applicant Total
149
Review Days
75
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Basic Information
- Device Name
- OLYMPUS TJF-140R/JF-140R EVIS DUODENOVIDEOSCOPES AND ACCESSORIES, OLYMPUS MAJ-311/MAJ-411 DISTAL COVERS
- K Number
- K980465
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Olympus America, Inc.
- Date Received
- February 5, 1998
- Decision Date
- April 21, 1998
- Product Code
- FDT
- 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 |
|---|---|---|---|
| FDT | Duodenoscope And Accessories, Flexible/Rigid | FDA class 2 | Gastroenterology, Urology |
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