The following data is part of a premarket notification filed by Brainlab, Ag with the FDA for Vectorvision Hip Sr.
Device ID | K063028 |
510k Number | K063028 |
Device Name: | VECTORVISION HIP SR |
Classification | Neurological Stereotaxic Instrument |
Applicant | BRAINLAB, AG KAPELLENSTR. 12 Feldkirchen, DE 85622 |
Contact | Rainer Birkenbach |
Correspondent | Rainer Birkenbach BRAINLAB, AG KAPELLENSTR. 12 Feldkirchen, DE 85622 |
Product Code | HAW |
CFR Regulation Number | 882.4560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-10-02 |
Decision Date | 2006-12-12 |
Summary: | summary |