FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLEX SIGMOIDOSCOPE LIGHT SOURCE MODEL #45150
K Number: K893440
·
Decision Jul 28, 1989
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
25
Applicant Total
111
Review Days
86
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Basic Information
- Device Name
- FLEX SIGMOIDOSCOPE LIGHT SOURCE MODEL #45150
- K Number
- K893440
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Welch Allyn, Inc.
- Date Received
- May 3, 1989
- Decision Date
- July 28, 1989
- Product Code
- FFS
- 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 |
|---|---|---|---|
| FFS | Image, Illumination, Fiberoptic, For Endoscope | FDA class 2 | Gastroenterology, Urology |
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