EARSCAN DSP-1 PURE TONE AUDIOMETER— 510(k) K913589
Substantially EquivalentMicro Audiometrics Corp.
FDA 510(k) clearance K913589 for EARSCAN DSP-1 PURE TONE AUDIOMETER, Substantially Equivalent on 1991-11-05. Applicant: Micro Audiometrics Corp.. Device class: 2.
Clearance details
- Applicant
- Micro Audiometrics Corp.
- 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
- South Daytona, FL, US
Recent devices under product code EWO
view allMore clearances from Micro Audiometrics Corp.
view allAdverse 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.