UNIT, LIQUID, OXYGEN, PORTABLE— 510(k) K813453

Name: FDA 510(k) clearance K813453
Creator: U.S. Food and Drug Administration
Published: 1982-01-12

Substantially Equivalent

Pensee Medical Corp.

FDA 510(k) clearance K813453 for UNIT, LIQUID, OXYGEN, PORTABLE, Substantially Equivalent on 1982-01-12. Applicant: Pensee Medical Corp.. Device class: 2.

Clearance details

Applicant: Pensee Medical Corp.
Product code: Code BYJ
Device class: Class 2
Regulation: 21 CFR 868.5655
Advisory panel: Anesthesiology
Date received: 1981-12-10
Decision date: 1982-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BYJ

view all

K130068 — DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS)2013-07-19
K113767 — MOUNTED MEDICAL OXYGEN SYSTEM2012-06-29
K103324 — PRECISION LIQUID OXYGEN SYSTEM2011-04-21
K101272 — MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-32010-08-20
K081779 — GOLOX-932008-09-19

Adverse events under product code BYJ

product code BYJ

Death: 16
Total: 16

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.