The following data is part of a premarket notification filed by Karl Storz Endoscopy America, Inc. with the FDA for View 1 Imaging.
| Device ID | K112480 |
| 510k Number | K112480 |
| Device Name: | VIEW 1 IMAGING |
| Classification | System, Image Processing, Radiological |
| 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 | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-29 |
| Decision Date | 2011-12-13 |
| Summary: | summary |