ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC— 510(k) K962995
Substantially EquivalentOtodynamics, Ltd.
FDA 510(k) clearance K962995 for ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC, Substantially Equivalent on 1997-01-10. Applicant: Otodynamics, Ltd.. Device class: 2.
Clearance details
- Applicant
- Otodynamics, Ltd.
- Product code
- Code EWO
- Device class
- Class 2
- Regulation
- 21 CFR 874.1050
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hatfield Herts Al10 8bb, GB
Recent devices under product code EWO
view allMore clearances from Otodynamics, Ltd.
view all- K143395 — 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
- K072033 — OTODYNAMICS OTOPORT
- K983350 — ILO292 DP ECHOPORT PLUS OAE SYSTEM
- K983351 — ILO292 DP ECHOPORT PLUS OAE SYSTEM
- K983352 — ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK
Adverse events under product code EWO
product code EWO- Other
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.