The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Image1 Gi Ccu Model 22203020-114.
| Device ID | K111997 |
| 510k Number | K111997 |
| Device Name: | IMAGE1 GI CCU MODEL 22203020-114 |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVE. El Segundo, CA 90245 |
| Contact | Winkie Wong |
| Correspondent | Winkie Wong KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVE. El Segundo, CA 90245 |
| Product Code | FET |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-13 |
| Decision Date | 2012-04-06 |
| Summary: | summary |