CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEM— 510(k) K981697

Name: FDA 510(k) clearance K981697
Creator: U.S. Food and Drug Administration
Published: 1998-10-14

Substantially Equivalent

Cambridge Heart, Inc.

FDA 510(k) clearance K981697 for CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEM, Substantially Equivalent on 1998-10-14. 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: 1998-05-11
Decision date: 1998-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, 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.