CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002— 510(k) K002230

Name: FDA 510(k) clearance K002230
Creator: U.S. Food and Drug Administration
Published: 2000-08-18

Substantially Equivalent

Cambridge Heart, Inc.

FDA 510(k) clearance K002230 for CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002, Substantially Equivalent on 2000-08-18. 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: 2000-07-24
Decision date: 2000-08-18
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 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.