ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATOR SYSTEM— 510(k) K014078

Name: FDA 510(k) clearance K014078
Creator: U.S. Food and Drug Administration
Published: 2002-01-08

Substantially Equivalent

On Site Gas Systems, Inc.

FDA 510(k) clearance K014078 for ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATOR SYSTEM, Substantially Equivalent on 2002-01-08. Applicant: On Site Gas Systems, Inc.. Device class: 2.

Clearance details

Applicant: On Site Gas Systems, Inc.
Product code: Code CAW
Device class: Class 2
Regulation: 21 CFR 868.5440
Advisory panel: Anesthesiology
Date received: 2001-12-11
Decision date: 2002-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Britain, CT, US

Download summary PDF View on FDA.gov ↗

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More clearances from On Site Gas Systems, Inc.

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K092636 — POGS, MODEL 65/1302010-01-07
K063454 — POGS, MODEL 33C2007-05-09
K041664 — PORTABLE OXYGEN GENERATION SYSTEM: POGS 33C2004-07-29
K030920 — POGS 332004-03-10
K021581 — HEMOSORB2002-07-12

Adverse events under product code CAW

product code CAW

Death: 204
Injury: 573
Malfunction: 1,400
Other: 6
Total: 2,183

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.