CARDIODIRECT, MODELS 12M, 12I, 12S— 510(k) K024283

Substantially Equivalent

Reynolds Medical , Ltd.

FDA 510(k) clearance K024283 for CARDIODIRECT, MODELS 12M, 12I, 12S, Substantially Equivalent on 2003-08-01. Applicant: Reynolds Medical , Ltd..

Clearance details

Applicant: Reynolds Medical , Ltd.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2002-12-23
Decision date: 2003-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hasbrouck, NJ, US

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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.