MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS— 510(k) K013564

Substantially Equivalent

Cambridge Heart, Inc.

FDA 510(k) clearance K013564 for MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS, 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.