LIFECARD CF 7 DAY— 510(k) K011837

Substantially Equivalent

Reynolds Medical , Ltd.

FDA 510(k) clearance K011837 for LIFECARD CF 7 DAY, Substantially Equivalent on 2001-07-13. Applicant: Reynolds Medical , Ltd..

Clearance details

Applicant: Reynolds Medical , Ltd.
Product code: Code MWJ
Advisory panel: Cardiovascular
Date received: 2001-06-12
Decision date: 2001-07-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Hasbrouck, NJ, US

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Adverse events under product code MWJ

product code MWJ

Other: 1
Total: 1

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.