The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Microscope Navigation Software.
| Device ID | K172820 |
| 510k Number | K172820 |
| Device Name: | Microscope Navigation Software |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | Brainlab AG Olof-Palme-Str. 9 Munich, DE |
| Contact | Alexander Schwiersch |
| Correspondent | Alexander Schwiersch Brainlab AG Olof-Palme-Str. 9 Munich, DE |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-18 |
| Decision Date | 2018-03-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056481140557 | K172820 | 000 |