DeviceClearance

INTELLIVUE GAS MODULES, MODELS G5 M1019A AND G1 M1013A— 510(k) K053204

Substantially Equivalent

Draeger Medical AG & Co. Kgaa

FDA 510(k) clearance K053204 for INTELLIVUE GAS MODULES, MODELS G5 M1019A AND G1 M1013A, Substantially Equivalent on 2006-02-03. Applicant: Draeger Medical AG & Co. Kgaa. Device class: 2.

Clearance details

Applicant
Draeger Medical AG & Co. Kgaa
Product code
Code CCK
Device class
Class 2
Regulation
21 CFR 868.1400
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Telford, PA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code CCK

product code CCK
Death
3
Malfunction
11,428
Total
11,431

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 →

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