The following data is part of a premarket notification filed by Medrx, Inc. with the FDA for Oto Wizzard.
| Device ID | K981511 |
| 510k Number | K981511 |
| Device Name: | OTO WIZZARD |
| Classification | Audiometer |
| Applicant | MEDRX, INC. 7777 131ST ST., SUITE 6 Seminole, FL 33776 |
| Contact | Jeffrey A Mclaughlin |
| Correspondent | Jeffrey A Mclaughlin MEDRX, INC. 7777 131ST ST., SUITE 6 Seminole, FL 33776 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-28 |
| Decision Date | 1998-07-24 |