DeviceClearance

SLEEPAPP— 510(k) K182202

Substantially Equivalent

Comfort Acrylics, Inc.

FDA 510(k) clearance K182202 for SLEEPAPP, Substantially Equivalent on 2019-01-11. Applicant: Comfort Acrylics, Inc.. Device class: 2.

Clearance details

Applicant
Comfort Acrylics, Inc.
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
Abbreviated
Location
Camas, WA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code LRK

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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.