GOLOX-93— 510(k) K081779

Substantially Equivalent

Respironics, Inc.

FDA 510(k) clearance K081779 for GOLOX-93, Substantially Equivalent on 2008-09-19. Applicant: Respironics, Inc..

Clearance details

Applicant: Respironics, Inc.
Product code: Code BYJ
Advisory panel: Anesthesiology
Date received: 2008-06-23
Decision date: 2008-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Murrysville, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BYJ

product code BYJ

Death: 16
Total: 16

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.