FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, COMED ASADAL-M1
K Number: K131721
·
Decision Jul 22, 2014
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
55
Applicant Total
1
Review Days
405
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Basic Information
- Device Name
- EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, COMED ASADAL-M1
- K Number
- K131721
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5990
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Comed Medical Systems Co., Ltd.
- Date Received
- June 12, 2013
- Decision Date
- July 22, 2014
- Product Code
- LNS
- 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 |
|---|---|---|---|
| LNS | Lithotriptor, Extracorporeal Shock-Wave, Urological | FDA class 2 | Gastroenterology, Urology |
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