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 | K180146 |
| 510k Number | K180146 |
| Device Name: | KARL STORZ ICG Imaging System |
| Classification | Endoscope, Neurological |
| Applicant | KARL STORZ Endoscopy America, Inc. 2151 E. Grand Avenue El Segundo, CA 90245 |
| Contact | Winkie Wong |
| Correspondent | Winkie Wong KARL STORZ Endoscopy America, Inc. 2151 E. Grand Avenue El Segundo, CA 90245 |
| Product Code | GWG |
| CFR Regulation Number | 882.1480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2018-01-18 |
| Decision Date | 2018-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551388815 | K180146 | 000 |
| 04048551388792 | K180146 | 000 |
| 04048551388785 | K180146 | 000 |