The following data is part of a premarket notification filed by Eckert & Ziegler Bebig Gmbh with the FDA for Hdrplus, Add In Prostate Module For Hdrplus.
| Device ID | K123263 |
| 510k Number | K123263 |
| Device Name: | HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | ECKERT & ZIEGLER BEBIG GMBH MUURZWALUW 30 Veenendaal, NL 3905rz |
| Contact | Hub Van De Bergh |
| Correspondent | Hub Van De Bergh ECKERT & ZIEGLER BEBIG GMBH MUURZWALUW 30 Veenendaal, NL 3905rz |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-18 |
| Decision Date | 2013-04-04 |
| Summary: | summary |