The following data is part of a premarket notification filed by Medispec, Ltd. with the FDA for Econolith Em1000.
| Device ID | K063504 |
| 510k Number | K063504 |
| Device Name: | ECONOLITH EM1000 |
| Classification | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | MEDISPEC, LTD. 12850 MIDDLEBROOK RD. STE. 1 Germantown, MD 20874 |
| Contact | Anil Dhingra |
| Correspondent | Anil Dhingra MEDISPEC, LTD. 12850 MIDDLEBROOK RD. STE. 1 Germantown, MD 20874 |
| Product Code | LNS |
| CFR Regulation Number | 876.5990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-20 |
| Decision Date | 2007-03-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016498394 | K063504 | 000 |
| 07290016498387 | K063504 | 000 |
| 07290016498370 | K063504 | 000 |
| 07290016498363 | K063504 | 000 |
| 07290016498356 | K063504 | 000 |