The following data is part of a premarket notification filed by Biosense Webster with the FDA for Trudi Navigation System.
| Device ID | K192397 |
| 510k Number | K192397 |
| Device Name: | TruDi Navigation System |
| Classification | Ear, Nose, And Throat Stereotaxic Instrument |
| Applicant | Biosense Webster 33 Technology Drive Irvine, CA 92618 |
| Contact | David Locke |
| Correspondent | David Locke Acclarent Inc. 33 Technology Drive Irvine, CA 92618 |
| Product Code | PGW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-03 |
| Decision Date | 2020-01-30 |
| Summary: | summary |