RESPIRONICS VENT EASY OXYGEN ENRICHME— 510(k) K842605

Substantially Equivalent

Respironics, Inc.

FDA 510(k) clearance K842605 for RESPIRONICS VENT EASY OXYGEN ENRICHME, Substantially Equivalent on 1984-07-27. Applicant: Respironics, Inc..

Clearance details

Applicant: Respironics, Inc.
Product code: Code CAE
Advisory panel: Anesthesiology
Date received: 1984-07-05
Decision date: 1984-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monroeville, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAE

product code CAE

Death: 4
Total: 4

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.