LIFE CORP. OXYGEN PAC— 510(k) K855092

Name: FDA 510(k) clearance K855092
Creator: U.S. Food and Drug Administration
Published: 1986-01-21

Substantially Equivalent

Life Corp.

FDA 510(k) clearance K855092 for LIFE CORP. OXYGEN PAC, Substantially Equivalent on 1986-01-21. Applicant: Life Corp.. Device class: 2.

Clearance details

Applicant: Life Corp.
Product code: Code BTL
Device class: Class 2
Regulation: 21 CFR 868.5925
Advisory panel: Anesthesiology
Date received: 1985-12-20
Decision date: 1986-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menomonee Falls, WI, US

Download summary PDF View on FDA.gov ↗

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More clearances from Life Corp.

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K910699 — LIFE-02 (NON-REFILLABLE CYLINDER)1991-06-18
K910434 — LIFE OXYGENPAC FOR TRAINED MEDICAL PERSONNEL1991-06-17
K910435 — LIFE OXYGENPAC 6/12 LPM1991-06-17
K910201 — LIFE O21991-02-01

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.