EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER— 510(k) K131817
Substantially EquivalentOsmunda Medical Device Consulting Co., Ltd.
FDA 510(k) clearance K131817 for EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, Substantially Equivalent on 2014-09-26. Applicant: Osmunda Medical Device Consulting Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Osmunda Medical Device Consulting Co., Ltd.
- Product code
- Code LNS
- Device class
- Class 2
- Regulation
- 21 CFR 876.5990
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Guangzhou, Guangdong, CN
Recent devices under product code LNS
view allAdverse events under product code LNS
product code LNS- Death
- 4
- Injury
- 320
- Total
- 324
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.