DeviceClearance

DATACAPTOR— 510(k) K013019

Substantially Equivalent

Capsule Technologie

FDA 510(k) clearance K013019 for DATACAPTOR, Substantially Equivalent on 2001-12-18. Applicant: Capsule Technologie. Device class: 2.

Clearance details

Applicant
Capsule Technologie
Product code
Code MWI
Device class
Class 2
Regulation
21 CFR 870.2300
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Deer Field, IL, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code MWI

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More clearances from Capsule Technologie

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Adverse events under product code MWI

product code MWI
Death
16
Malfunction
963
Total
979

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 K013019

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 K013019.

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