MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3— 510(k) K101272

Substantially Equivalent

Essex Industries, Inc.

FDA 510(k) clearance K101272 for MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3, Substantially Equivalent on 2010-08-20. Applicant: Essex Industries, Inc..

Clearance details

Applicant: Essex Industries, Inc.
Product code: Code BYJ
Advisory panel: Anesthesiology
Date received: 2010-05-06
Decision date: 2010-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, 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.