THE PILOT AUDIOMETER— 510(k) K951527
Substantially EquivalentAmerican Electromedics Corp.
FDA 510(k) clearance K951527 for THE PILOT AUDIOMETER, Substantially Equivalent on 1995-05-03. Applicant: American Electromedics Corp.. Device class: 2.
Clearance details
- Applicant
- American Electromedics 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
- Amherst, NH, US
Recent devices under product code EWO
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view all- K983049 — AMERICAN ELECTROMEDICS QUIK TYMP 1 (QT1) TYMPANOMETER WITH INTERGRAL PRINTER
- K983051 — AMERICAN ELECTROMEDICS RACE CA TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER
- K983046 — AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRINTER
- K983048 — AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER
- K972221 — K 15 AUDIOMETER
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.