FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
LM-9300 ELMA Lithotripter
K Number: K142561
·
Decision Mar 20, 2015
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
55
Applicant Total
3
Review Days
190
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- LM-9300 ELMA Lithotripter
- K Number
- K142561
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 876.5990
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lite-Med, Inc.
- Date Received
- September 11, 2014
- Decision Date
- March 20, 2015
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LNS), ordered by most recent decision date.
Break Wave
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Break Wave
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Extracorporeal Shock Wave Lithotripter (U200)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Delta III Pro
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LM-9300 Plus Lithotripter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Modulith SLX-F2
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology