SLEEP STAGER— 510(k) K850541

Substantially Equivalent

Oxford Medilog, Inc.

FDA 510(k) clearance K850541 for SLEEP STAGER, Substantially Equivalent on 1985-08-02. Applicant: Oxford Medilog, Inc..

Clearance details

Applicant: Oxford Medilog, Inc.
Product code: Code OLT
Advisory panel: Neurology
Date received: 1985-02-11
Decision date: 1985-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, US

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Adverse events under product code OLT

product code OLT

Other: 1
Total: 1

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.