CAMBRIDGE HEART MODEL CH 2000 CARDIAC DIAGNOSTIC SYSTEM— 510(k) K011324

Substantially Equivalent

Cambridge Heart, Inc.

FDA 510(k) clearance K011324 for CAMBRIDGE HEART MODEL CH 2000 CARDIAC DIAGNOSTIC SYSTEM, Substantially Equivalent on 2001-05-23. Applicant: Cambridge Heart, Inc..

Clearance details

Applicant: Cambridge Heart, Inc.
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 2001-05-01
Decision date: 2001-05-23
Decision: Substantially Equivalent
Clearance type: Special
Location: South West Ranches, FL, US

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Adverse events under product code DQK

product code DQK

Death: 10
Injury: 225
Malfunction: 2,123
Other: 2
Total: 2,360

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.