DeviceClearance

MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS— 510(k) K092244

Substantially Equivalent

Diagnostic Group, LLC

FDA 510(k) clearance K092244 for MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS, Substantially Equivalent on 2010-03-01. Applicant: Diagnostic Group, LLC. Device class: 2.

Clearance details

Applicant
Diagnostic Group, LLC
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
Minnesota, MN, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code EWO

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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.