PureSleep (OTC use)— 510(k) K190058

Substantially Equivalent

Sleep Science Partners, Inc.

FDA 510(k) clearance K190058 for PureSleep (OTC use), Substantially Equivalent on 2019-04-11. Applicant: Sleep Science Partners, Inc..

Clearance details

Applicant: Sleep Science Partners, Inc.
Product code: Code LRK
Advisory panel: Dental
Date received: 2019-01-11
Decision date: 2019-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Larkspur, CA, 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.