LIQUID OXYGEN UNIT, PORTABLE 73BYJ— 510(k) K780098

Substantially Equivalent

Andonian Cryogenics, Inc.

FDA 510(k) clearance K780098 for LIQUID OXYGEN UNIT, PORTABLE 73BYJ, Substantially Equivalent on 1978-03-02. Applicant: Andonian Cryogenics, Inc..

Clearance details

Applicant
Andonian Cryogenics, Inc.
Product code
Code BYJ
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code BYJ

product code BYJ
Death
16
Total
16

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.