K061414

Substantially Equivalent

EXPEDITIONARY DELPLOYABLE OXYGEN CONCENTRATION SYSTEM (EDOCS), MODELS 120B AND 30;MOBILE OXYGEN STORAGE TANK (MOST), MOD

Applicant
Pacific Consolidated Industries, LLC
Product code
CAW
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Riverside, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code CAW

product code CAW
Death
204
Injury
573
Malfunction
1,400
Other
6
Total
2,183

Source: openFDA MAUDE database, through . 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.