K063504 is an FDA 510(k) clearance for the ECONOLITH EM1000, a Lithotriptor, Extracorporeal Shock-wave, Urological (Class II — Special Controls, product code LNS), submitted by Medispec, Ltd. (Germantown, US). The FDA issued a Cleared decision on March 9, 2007, 109 days after receiving the submission on November 20, 2006. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5990.
| 510(k) Number | K063504 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 20, 2006 |
| Decision Date | March 09, 2007 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LNS — Lithotriptor, Extracorporeal Shock-wave, Urological |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5990 |