CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000— 510(k) K013565

Substantially Equivalent

Cambridge Heart, Inc.

FDA 510(k) clearance K013565 for CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000, Substantially Equivalent on 2001-11-21. Applicant: Cambridge Heart, Inc..

Clearance details

Applicant: Cambridge Heart, Inc.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2001-10-26
Decision date: 2001-11-21
Decision: Substantially Equivalent
Clearance type: Special
Location: South West Ranches, FL, US

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Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.