The following data is part of a premarket notification filed by Brainlab Medizinische Computersysteme Gmbh with the FDA for Brainscan Workstation.
| Device ID | K915819 |
| 510k Number | K915819 |
| Device Name: | BRAINSCAN WORKSTATION |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | BRAINLAB MEDIZINISCHE COMPUTERSYSTEME GMBH WITTELSBACHERSTR 8 D-8011 POING B MUCHEN West Germany, GR |
| Contact | Stefan Vilsmeier |
| Correspondent | Stefan Vilsmeier BRAINLAB MEDIZINISCHE COMPUTERSYSTEME GMBH WITTELSBACHERSTR 8 D-8011 POING B MUCHEN West Germany, GR |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-30 |
| Decision Date | 1992-05-11 |