Device Classification Name |
Ear, Nose, And Throat Stereotaxic Instrument
|
510(k) Number |
K161555 |
Device Name |
KARL STORZ NAV1 Electromagnetic Navigation System |
Applicant |
KARL STORZ Endoscopy America, Inc. |
2151 E. Grand Ave |
El Segundo,
CA
90245
|
|
Applicant Contact |
Leigh Spotten |
Correspondent |
KARL STORZ Endoscopy America, Inc. |
2151 E. Grand Ave |
El Segundo,
CA
90245
|
|
Correspondent Contact |
Leigh Spotten |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 06/06/2016 |
Decision Date | 10/21/2016 |
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
|
|
|