The following data is part of a premarket notification filed by Brainlab Med. Computersysteme Gmbh with the FDA for Brainlab Sterotatic Headring.
| Device ID | K952390 |
| 510k Number | K952390 |
| Device Name: | BRAINLAB STEROTATIC HEADRING |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | BRAINLAB MED. COMPUTERSYSTEME GMBH GRUBER STRABE 46C 85586 Poing/munchen, DE 85586 |
| Contact | Stefan Vilsmeier |
| Correspondent | Stefan Vilsmeier BRAINLAB MED. COMPUTERSYSTEME GMBH GRUBER STRABE 46C 85586 Poing/munchen, DE 85586 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-22 |
| Decision Date | 1996-02-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056481125912 | K952390 | 000 |
| 04056481004064 | K952390 | 000 |