DeviceClearance

Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX— 510(k) K213972

Substantially Equivalent

Ge Healthcare Information Technologies, Inc.

FDA 510(k) clearance K213972 for Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX, Substantially Equivalent on 2022-02-17. Applicant: Ge Healthcare Information Technologies, Inc.. Device class: 2.

Clearance details

Applicant
Ge Healthcare Information Technologies, Inc.
Product code
Code DQK
Device class
Class 2
Regulation
21 CFR 870.1425
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Wauwatosa, WI, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code DQK

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Adverse events under product code DQK

product code DQK
Death
10
Injury
225
Malfunction
2,123
Other
2
Total
2,360

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 K213972

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 K213972.

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