The following data is part of a premarket notification filed by Osram Sylvania, Inc. with the FDA for Osram Itos.
| Device ID | K110326 |
| 510k Number | K110326 |
| Device Name: | OSRAM ITOS |
| Classification | Otoscope |
| Applicant | OSRAM SYLVANIA, INC. 1801 ROCKVILLE PIKE SUITE 300 Rockville, MD 20852 |
| Contact | Marie A Schroeder |
| Correspondent | Marie A Schroeder OSRAM SYLVANIA, INC. 1801 ROCKVILLE PIKE SUITE 300 Rockville, MD 20852 |
| Product Code | ERA |
| CFR Regulation Number | 874.4770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-03 |
| Decision Date | 2011-10-27 |
| Summary: | summary |