DeviceClearance

Helianthus— 510(k) K202822

Substantially Equivalent

Metaltronica Spa

FDA 510(k) clearance K202822 for Helianthus, Substantially Equivalent on 2021-12-15. Applicant: Metaltronica Spa. Device class: 2.

Clearance details

Applicant
Metaltronica Spa
Product code
Code MUE
Device class
Class 2
Regulation
21 CFR 892.1715
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Pomezia Rm, IT
Download summary PDFView on FDA.gov ↗

Recent devices under product code MUE

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Adverse events under product code MUE

product code MUE
Death
5
Other
1
Total
6

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.