DeviceClearance

Diamond Digital Sleep Orthotic (DDSO)— 510(k) K202499

Substantially Equivalent

Diamond Orthotic Laboratory

FDA 510(k) clearance K202499 for Diamond Digital Sleep Orthotic (DDSO), Substantially Equivalent on 2020-09-03. Applicant: Diamond Orthotic Laboratory. Device class: 2.

Clearance details

Applicant
Diamond Orthotic Laboratory
Product code
Code LRK
Device class
Class 2
Regulation
21 CFR 872.5570
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
La Mesa, CA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code LRK

view all

Adverse events under product code LRK

product code LRK
Injury
246
Malfunction
1,044
Total
1,290

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.