The following data is part of a premarket notification filed by Brainlab, Ag with the FDA for Patxfer Rt.
| Device ID | K040931 |
| 510k Number | K040931 |
| Device Name: | PATXFER RT |
| Classification | System, Image Processing, Radiological |
| Applicant | BRAINLAB, AG AMMERTHALSTRASSE 8 Heimstetten, DE 85551 |
| Contact | Rainer Birkenbach |
| Correspondent | Rainer Birkenbach BRAINLAB, AG AMMERTHALSTRASSE 8 Heimstetten, DE 85551 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-09 |
| Decision Date | 2004-07-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056481000301 | K040931 | 000 |