DeviceClearance

DMX— 510(k) K223550

Substantially Equivalent

Del Medical, Inc.

FDA 510(k) clearance K223550 for DMX, Substantially Equivalent on 2023-04-10. Applicant: Del Medical, Inc.. Device class: 2.

Clearance details

Applicant
Del Medical, Inc.
Product code
Code KPR
Device class
Class 2
Regulation
21 CFR 892.1680
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Bloomingdale, IL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code KPR

product code KPR
Other
6
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.