FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LITHOTRIPTOR SYSTEM MODEL 27080
K Number: K905553
·
Decision Jun 4, 1991
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
60
Applicant Total
1
Review Days
175
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Basic Information
- Device Name
- LITHOTRIPTOR SYSTEM MODEL 27080
- K Number
- K905553
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4480
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Karl Storz GmbH & Co. (Kst)
- Date Received
- December 11, 1990
- Decision Date
- June 4, 1991
- Product Code
- FFK
- 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 |
|---|---|---|---|
| FFK | Lithotriptor, Electro-Hydraulic | FDA class 2 | Gastroenterology, Urology |
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