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

Name: FDA 510(k) clearance K013564
Creator: U.S. Food and Drug Administration
Published: 2001-11-21

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.. Device class: 2.

Clearance details

Applicant: Cambridge Heart, Inc.
Product code: Code DPS
Device class: Class 2
Regulation: 21 CFR 870.2340
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

Download summary PDF View on FDA.gov ↗

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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.