DeviceClearance

DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES— 510(k) K052582

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K052582 for DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES, Substantially Equivalent on 2005-10-14. Applicant: GE Healthcare. Device class: 2.

Clearance details

Applicant
GE Healthcare
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
Needham, MA, 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 →

Recalls naming K052582

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 K052582.

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