LIFE O2— 510(k) K910201

Substantially Equivalent

Life Corp.

FDA 510(k) clearance K910201 for LIFE O2, Substantially Equivalent on 1991-02-01. Applicant: Life Corp..

Clearance details

Applicant: Life Corp.
Product code: Code BTL
Advisory panel: Anesthesiology
Date received: 1991-01-18
Decision date: 1991-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menomonee Falls, WI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTL

product code BTL

Death: 8
Malfunction: 3,256
Other: 1
Total: 3,265

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.