The following data is part of a premarket notification filed by Otodynamics, Ltd. with the FDA for Ilo88. Otodynamic Analyser, Kit System For Pc.
| Device ID | K962995 |
| 510k Number | K962995 |
| Device Name: | ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC |
| Classification | Audiometer |
| Applicant | OTODYNAMICS, LTD. 36 BEACONSFIELD RD., Hatfield Herts Al10 8bb, GB Al10 8bb |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-01 |
| Decision Date | 1997-01-10 |