Device Classification Name |
confocal optical imaging
|
510(k) Number |
K231854 |
Device Name |
1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM |
Applicant |
Stryker |
5900 Optical Court |
San Jose,
CA
95138
|
|
Applicant Contact |
April Malmborg |
Correspondent |
Stryker |
5900 Optical Court |
San Jose,
CA
95138
|
|
Correspondent Contact |
April Malmborg |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/23/2023 |
Decision Date | 09/20/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|