The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Aida Hd Connect With Smartscreen / Blu-ray Drive / Smartscreen With Blu-ray Drive.
| Device ID | K103308 |
| 510k Number | K103308 |
| Device Name: | AIDA HD CONNECT WITH SMARTSCREEN / BLU-RAY DRIVE / SMARTSCREEN WITH BLU-RAY DRIVE |
| Classification | System, Image Processing, Radiological |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVE. El Segundo, CA 90245 |
| Contact | Crystal Dizol Hagan |
| Correspondent | Crystal Dizol Hagan KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVE. El Segundo, CA 90245 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-09 |
| Decision Date | 2011-08-29 |
| Summary: | summary |