The following data is part of a premarket notification filed by Pajunk Gmbh Medizintechnologie with the FDA for Brainpro, Brainpro Access.
| Device ID | K060808 |
| 510k Number | K060808 |
| Device Name: | BRAINPRO, BRAINPRO ACCESS |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | PAJUNK GMBH MEDIZINTECHNOLOGIE KARL-HALL-STRASSE 01 Geisingen, Baden-wurttemberg, DE 78187 |
| Contact | Christian Quass |
| Correspondent | Christian Quass PAJUNK GMBH MEDIZINTECHNOLOGIE KARL-HALL-STRASSE 01 Geisingen, Baden-wurttemberg, DE 78187 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-24 |
| Decision Date | 2006-07-25 |
| Summary: | summary |