DeviceClearance

RAOMER— 510(k) K894112

Substantially Equivalent

Niagara Corp.

FDA 510(k) clearance K894112 for RAOMER, Substantially Equivalent on 1989-07-25. Applicant: Niagara Corp.. Device class: 2.

Clearance details

Applicant
Niagara Corp.
Product code
Code INI
Device class
Class 2
Regulation
21 CFR 890.3800
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Stanley, NC, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code INI

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Adverse events under product code INI

product code INI
Injury
171
Other
1
Total
172

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.