The following data is part of a premarket notification filed by Brainlab, Ag with the FDA for Brainscan Conformal Rt Module.
Device ID | K971367 |
510k Number | K971367 |
Device Name: | BRAINSCAN CONFORMAL RT MODULE |
Classification | Accelerator, Linear, Medical |
Applicant | BRAINLAB, AG AMMERTHALSTRASSE 8 Heimstetten, DE 85551 |
Contact | Stefan Vilsmeier |
Correspondent | Stefan Vilsmeier BRAINLAB, AG AMMERTHALSTRASSE 8 Heimstetten, DE 85551 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-04-14 |
Decision Date | 1997-10-27 |