The following data is part of a premarket notification filed by Otodynamics, Ltd. with the FDA for Otoport Oae +abr Advance, Otoport Oae+abr Dp+te, Otoport Oae+abr Screener-otocheck Oae+abr, Otocheck Oae+abr Le, Otocheck Abr Screener-otodynamics Abr Upgrade Kit.
| Device ID | K143395 |
| 510k Number | K143395 |
| Device Name: | Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit |
| Classification | Audiometer |
| Applicant | OTODYNAMICS, LTD. 30-38 BEACONSFIELD RD. Hatfield, Herts, GB Al10 8bb |
| Contact | Julian Rutherford |
| Correspondent | Christopher M Sloan QUINTILES CONSULTING 1801 ROCKVILLE PIKE SUITE 300 Rockville, MD 20852 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-26 |
| Decision Date | 2015-02-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060396171079 | K143395 | 000 |
| 05060396171406 | K143395 | 000 |
| 05060396171390 | K143395 | 000 |
| 05060396171383 | K143395 | 000 |
| 05060396171284 | K143395 | 000 |
| 05060396171277 | K143395 | 000 |
| 05060396171260 | K143395 | 000 |
| 05060396171253 | K143395 | 000 |
| 05060396171246 | K143395 | 000 |
| 05060396171239 | K143395 | 000 |
| 05060396171222 | K143395 | 000 |
| 05060396171192 | K143395 | 000 |
| 05060396171185 | K143395 | 000 |
| 05060396171178 | K143395 | 000 |
| 05060396171161 | K143395 | 000 |
| 05060396171680 | K143395 | 000 |
| 05060396170058 | K143395 | 000 |
| 05060396170072 | K143395 | 000 |
| 05060396171062 | K143395 | 000 |
| 05060396171048 | K143395 | 000 |
| 05060396170676 | K143395 | 000 |
| 05060396170669 | K143395 | 000 |
| 05060396170652 | K143395 | 000 |
| 05060396170645 | K143395 | 000 |
| 05060396170638 | K143395 | 000 |
| 05060396170621 | K143395 | 000 |
| 05060396170614 | K143395 | 000 |
| 05060396170607 | K143395 | 000 |
| 05060396170430 | K143395 | 000 |
| 05060396170140 | K143395 | 000 |
| 05060396170126 | K143395 | 000 |
| 05060396170096 | K143395 | 000 |
| 05060396171116 | K143395 | 000 |