The following data is part of a premarket notification filed by Lite-med Inc with the FDA for Lite-med Lm-9200 Elma.
| Device ID | K103217 |
| 510k Number | K103217 |
| Device Name: | LITE-MED LM-9200 ELMA |
| Classification | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | LITE-MED INC 9TH FLOOR, 49 DONGXING ROAD XINYI DISTRICT Taipei City, TW 110 |
| Contact | Walt Hsu |
| Correspondent | Walt Hsu LITE-MED INC 9TH FLOOR, 49 DONGXING ROAD XINYI DISTRICT Taipei City, TW 110 |
| Product Code | LNS |
| CFR Regulation Number | 876.5990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-01 |
| Decision Date | 2011-09-28 |
| Summary: | summary |