CAMBRIDGE HEART HI-RES ECG ELECTRODE— 510(k) K962115

Name: FDA 510(k) clearance K962115
Creator: U.S. Food and Drug Administration
Published: 1996-08-29

Substantially Equivalent

Cambridge Heart, Inc.

FDA 510(k) clearance K962115 for CAMBRIDGE HEART HI-RES ECG ELECTRODE, Substantially Equivalent on 1996-08-29. Applicant: Cambridge Heart, Inc.. Device class: 2.

Clearance details

Applicant: Cambridge Heart, Inc.
Product code: Code DRX
Device class: Class 2
Regulation: 21 CFR 870.2360
Advisory panel: Cardiovascular
Date received: 1996-05-31
Decision date: 1996-08-29
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 DRX

product code DRX

Death: 6
Injury: 476
Other: 2
Total: 484

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.