CARE PAL, MODEL CPW-10X— 510(k) K091430

Name: FDA 510(k) clearance K091430
Creator: U.S. Food and Drug Administration
Published: 2009-08-21

Substantially Equivalent

Digio2 International Co., Ltd.

FDA 510(k) clearance K091430 for CARE PAL, MODEL CPW-10X, Substantially Equivalent on 2009-08-21. Applicant: Digio2 International Co., Ltd.. Device class: 2.

Clearance details

Applicant: Digio2 International Co., Ltd.
Product code: Code DRG
Device class: Class 2
Regulation: 21 CFR 870.2910
Advisory panel: Cardiovascular
Date received: 2009-05-14
Decision date: 2009-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flagstaff, AZ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DRG

product code DRG

Death: 5
Total: 5

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.