The following data is part of a premarket notification filed by Karl Storz Endoscopy_america, Inc. with the FDA for Karl Storz Icg Imaging System.
| Device ID | K202925 |
| 510k Number | K202925 |
| Device Name: | KARL STORZ ICG Imaging System |
| Classification | Confocal Optical Imaging |
| Applicant | KARL STORZ Endoscopy_America, Inc. 2151 E. Grand Avenue El Segundo, CA 90245 |
| Contact | Alita Mcelroy |
| Correspondent | Alita Mcelroy KARL STORZ Endoscopy_America, Inc. 2151 E. Grand Avenue El Segundo, CA 90245 |
| Product Code | OWN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-29 |
| Decision Date | 2020-12-17 |