FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LYELL SOUND
K Number: K954972
·
Decision Jan 24, 1996
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
0
Applicant Total
3
Review Days
89
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Basic Information
- Device Name
- LYELL SOUND
- K Number
- K954972
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.4590
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Venture Management Corp.
- Date Received
- October 27, 1995
- Decision Date
- January 24, 1996
- Product Code
- FBS
- 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 |
|---|---|---|---|
| FBS | Sound, Metal, Interconnected | FDA class 1 | Gastroenterology, Urology |