FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OMEGA ANGIOSCOPES (OMEGASCOPES)
K Number: K911090
·
Decision Jul 31, 1991
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
40
Applicant Total
3
Review Days
142
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Basic Information
- Device Name
- OMEGA ANGIOSCOPES (OMEGASCOPES)
- K Number
- K911090
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Omega Universal Technologies, Ltd.
- Date Received
- March 11, 1991
- Decision Date
- July 31, 1991
- Product Code
- LYK
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| LYK | Angioscope | FDA class 2 | Gastroenterology, Urology |
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