The following data is part of a premarket notification filed by Medstone Intl., Inc. with the FDA for Medstone, Uropro 2000, Tomographic Option.
| Device ID | K013620 |
| 510k Number | K013620 |
| Device Name: | MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION |
| Classification | System, X-ray, Tomographic |
| Applicant | MEDSTONE INTL., INC. 100 COLUMBIA, SUITE 100 Aliso Viejo, CA 92656 -4114 |
| Contact | Ron Bergeson |
| Correspondent | Ron Bergeson MEDSTONE INTL., INC. 100 COLUMBIA, SUITE 100 Aliso Viejo, CA 92656 -4114 |
| Product Code | IZF |
| CFR Regulation Number | 892.1740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-05 |
| Decision Date | 2002-01-22 |
| Summary: | summary |