DeviceClearance

OXYSURE PORTABLE OXYGEN GENERATOR, MODEL 615— 510(k) K052396

Substantially Equivalent

Oxysure Systems, Inc.

FDA 510(k) clearance K052396 for OXYSURE PORTABLE OXYGEN GENERATOR, MODEL 615, Substantially Equivalent on 2005-12-09. Applicant: Oxysure Systems, Inc.. Device class: 2.

Clearance details

Applicant
Oxysure Systems, Inc.
Product code
Code CAW
Device class
Class 2
Regulation
21 CFR 868.5440
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Frisco, TX, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code CAW

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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, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K052396

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K052396.

Data sourced from openFDA. This site is unofficial and independent of the FDA.