Device Classification Name |
ear, nose, and throat stereotaxic instrument
|
510(k) Number |
K192397 |
Device Name |
TruDi Navigation System |
Applicant |
Biosense Webster |
33 Technology Drive |
Irvine,
CA
92618
|
|
Applicant Contact |
David Locke |
Correspondent |
Acclarent Inc. |
33 Technology Drive |
Irvine,
CA
92618
|
|
Correspondent Contact |
David Locke |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 09/03/2019 |
Decision Date | 01/30/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|