The following data is part of a premarket notification filed by Otodynamics, Ltd. with the FDA for Otodynamics Otoport.
| Device ID | K072033 |
| 510k Number | K072033 |
| Device Name: | OTODYNAMICS OTOPORT |
| Classification | Audiometer |
| Applicant | OTODYNAMICS, LTD. 1676 VILLAGE GREEN SUITE A Crofton, MD 21114 |
| Contact | Christina Norris |
| Correspondent | Christina Norris OTODYNAMICS, LTD. 1676 VILLAGE GREEN SUITE A Crofton, MD 21114 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-24 |
| Decision Date | 2007-11-13 |
| Summary: | summary |