CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B— 510(k) K100508

Substantially Equivalent

Carematix, Inc.

FDA 510(k) clearance K100508 for CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B, Substantially Equivalent on 2010-05-05. Applicant: Carematix, Inc..

Clearance details

Applicant: Carematix, Inc.
Product code: Code DRG
Advisory panel: Cardiovascular
Date received: 2010-02-22
Decision date: 2010-05-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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.