The following data is part of a premarket notification filed by Otodynamics, Ltd. with the FDA for Ilo292 Dp Echoport Plus Oae System.
| Device ID | K983350 |
| 510k Number | K983350 |
| Device Name: | ILO292 DP ECHOPORT PLUS OAE SYSTEM |
| Classification | Audiometer |
| Applicant | OTODYNAMICS, LTD. P.O. BOX 4341 Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith OTODYNAMICS, LTD. P.O. BOX 4341 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 | 1998-09-23 |
| Decision Date | 1998-12-11 |