Day

November 22, 2000
PRODUCT Escort E300 Series Patient Monitor, intended use is as an electrocardiograph and respiration monitor. Recall #Z-030-1. REASON It is possible for the High Breath Rate Alarm to function incorrectly under certain conditions. CODE Serial numbers are non-sequential (there are gaps), are four digits long and include: 1001 to 4086. MANUFACTURER Medical Data Electronics, Arleta,...
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What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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