FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OLYMPUS OES OTV-S5C VIDEO SYSTEM
K Number: K971416
·
Decision Jul 16, 1997
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
97
Applicant Total
149
Review Days
91
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Basic Information
- Device Name
- OLYMPUS OES OTV-S5C VIDEO SYSTEM
- K Number
- K971416
- 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
- April 16, 1997
- Decision Date
- July 16, 1997
- Product Code
- FET
- 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 |
|---|---|---|---|
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FDA class 2 | Gastroenterology, Urology |
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