INSPIRON LIQUID OXYGEN SYSTEM— 510(k) K834290

Substantially Equivalent

Inspiron Corp.

FDA 510(k) clearance K834290 for INSPIRON LIQUID OXYGEN SYSTEM, Substantially Equivalent on 1984-02-04. Applicant: Inspiron Corp..

Clearance details

Applicant
Inspiron Corp.
Product code
Code BYJ
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walker, MI, 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.