PENOX HIGH FLOW MANIFOLD— 510(k) K853775

Name: FDA 510(k) clearance K853775
Creator: U.S. Food and Drug Administration
Published: 1985-11-29

Substantially Equivalent

Penox Technologies, Inc.

FDA 510(k) clearance K853775 for PENOX HIGH FLOW MANIFOLD, Substantially Equivalent on 1985-11-29. Applicant: Penox Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Penox Technologies, Inc.
Product code: Code BYJ
Device class: Class 2
Regulation: 21 CFR 868.5655
Advisory panel: Anesthesiology
Date received: 1985-09-10
Decision date: 1985-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittston, PA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Penox Technologies, Inc.

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K864667 — PENOX HOSPITAL BED1987-01-21
K863978 — PORTABLE LIQUID OXYGEN UNIT (MODIFICATION)1986-12-15
K862654 — MODIFIED PENOX LIFT CHAIR1986-07-18
K852109 — PENOX PERFORMER WHEELCHAIR1985-08-22
K851218 — PENOX LIFT CHAIR1985-06-21

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.