SLEEP APP— 510(k) K100185

Substantially Equivalent

Sleep Medicine Network, Inc.

FDA 510(k) clearance K100185 for SLEEP APP, Substantially Equivalent on 2010-11-19. Applicant: Sleep Medicine Network, Inc..

Clearance details

Applicant: Sleep Medicine Network, Inc.
Product code: Code LRK
Advisory panel: Dental
Date received: 2010-01-22
Decision date: 2010-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, OR, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LRK

product code LRK

Injury: 246
Malfunction: 1,044
Total: 1,290

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.