DeviceClearance

SCREENING AUDIOMETRY WORD RECOGNITION AUDIOMETRY— 510(k) K950888

Substantially Equivalent

Calmed Technology, Inc.

FDA 510(k) clearance K950888 for SCREENING AUDIOMETRY WORD RECOGNITION AUDIOMETRY, Substantially Equivalent on 1995-03-21. Applicant: Calmed Technology, Inc.. Device class: 2.

Clearance details

Applicant
Calmed Technology, Inc.
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
Union City, CA, US
Download summary PDFView on FDA.gov ↗

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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.