The following data is part of a premarket notification filed by Lite-med Inc. with the FDA for Lm-9300 Elma Lithotripter.
| Device ID | K142561 |
| 510k Number | K142561 |
| Device Name: | LM-9300 ELMA Lithotripter |
| Classification | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | LITE-MED INC. 9TH FLOOR, 49 DONGXING ROAD, XINYI DISTRICT Taipei, TW 11070 |
| Contact | Walt Hsu |
| Correspondent | Walt Hsu LITE-MED INC. 9TH FLOOR, 49 DONGXING ROAD, XINYI DISTRICT Taipei, TW 11070 |
| Product Code | LNS |
| CFR Regulation Number | 876.5990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-11 |
| Decision Date | 2015-03-20 |
| Summary: | summary |