Device Classification Name |
neurological stereotaxic instrument
|
510(k) Number |
K122096 |
Device Name |
KARL STORZ NAVIGATIONPANEL UNIT (NPU) 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 | 07/16/2012 |
Decision Date | 09/27/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|