DeviceClearance

MA 55 MAESTRO— 510(k) K063452

Substantially Equivalent

Maico Diagnostics (Diagnostic Group, LLC)

FDA 510(k) clearance K063452 for MA 55 MAESTRO, Substantially Equivalent on 2007-03-29. Applicant: Maico Diagnostics (Diagnostic Group, LLC). Device class: 2.

Clearance details

Applicant
Maico Diagnostics (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
Eden Prairie, 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.