DeviceClearance

D-VAPOR— 510(k) K042276

Substantially Equivalent

Draeger Medical, Inc.

FDA 510(k) clearance K042276 for D-VAPOR, Substantially Equivalent on 2004-09-23. Applicant: Draeger Medical, Inc.. Device class: 2.

Clearance details

Applicant
Draeger Medical, Inc.
Product code
Code CAD
Device class
Class 2
Regulation
21 CFR 868.5880
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Telford, PA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code CAD

product code CAD
Malfunction
3,275
Total
3,275

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 K042276

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 K042276.

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