DeviceClearance

DIGNITY 100— 510(k) K082246

Substantially Equivalent

Dignity Medical Devices, Inc.

FDA 510(k) clearance K082246 for DIGNITY 100, Substantially Equivalent on 2008-09-09. Applicant: Dignity Medical Devices, Inc.. Device class: 1.

Clearance details

Applicant
Dignity Medical Devices, Inc.
Product code
Code IOR
Device class
Class 1
Regulation
21 CFR 890.3850
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Maple Grove, MN, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code IOR

view all

Adverse events under product code IOR

product code IOR
Death
10
Injury
232
Other
2
Total
244

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.