The following data is part of a premarket notification filed by Xmar Corp. with the FDA for Prognost Es, Model 0302 0000.
| Device ID | K011290 |
| 510k Number | K011290 |
| Device Name: | PROGNOST ES, MODEL 0302 0000 |
| Classification | System, X-ray, Tomographic |
| Applicant | XMAR CORP. 2222 DELAWARE DR. Cleveland Heights, OH 44106 -3115 |
| Contact | Neil Barrett |
| Correspondent | Neil Barrett XMAR CORP. 2222 DELAWARE DR. Cleveland Heights, OH 44106 -3115 |
| Product Code | IZF |
| CFR Regulation Number | 892.1740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-27 |
| Decision Date | 2001-05-30 |