PROPHET— 510(k) K953884

Name: FDA 510(k) clearance K953884
Creator: U.S. Food and Drug Administration
Published: 1995-10-27

Substantially Equivalent

Qualitone

FDA 510(k) clearance K953884 for PROPHET, Substantially Equivalent on 1995-10-27. Applicant: Qualitone. Device class: 2.

Clearance details

Applicant: Qualitone
Product code: Code EWO
Device class: Class 2
Regulation: 21 CFR 874.1050
Advisory panel: Ear, Nose, Throat
Date received: 1995-08-17
Decision date: 1995-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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More clearances from Qualitone

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K961827 — IN-THE-EAR1996-07-03
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K955359 — CYBER III OPTION UM, UC312, UC10, UCIC1995-12-19
K935348 — ODYSSEY CLINICAL AUDIOMETER1994-02-09
K935289 — PRO FIT-CYBER II OPTION1993-12-22

Adverse events under product code EWO

product code EWO

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.