The following data is part of a premarket notification filed by Soterix Medical, Inc. with the FDA for Neural Navigator.
| Device ID | K191422 |
| 510k Number | K191422 |
| Device Name: | Neural Navigator |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | Soterix Medical, Inc. 237 W 35 ST, 1401 New York, NY 10001 |
| Contact | Abhishek Datta |
| Correspondent | Abhishek Datta Soterix Medical, Inc. 237 W 35 ST, 1401 New York, NY 10001 |
| Product Code | HAW |
| Subsequent Product Code | GWF |
| Subsequent Product Code | IKN |
| Subsequent Product Code | OBP |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-29 |
| Decision Date | 2020-04-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08720299953703 | K191422 | 000 |