S&W MEDICO TEKNIK A/S -Patient monitoring

WARN 09/06/96 S&W MEDICO TEKNIK A/S -Patient monitoring

1. The software for the device identified as the Diascope traveller has been modified to add color to the monitor display. This is a very significant change since a new graphic controller (new hardware) had to be used in addition to a new color LCD display and a new set of codes (new software) had to be implemented to take advantage of the new color options. The 510(k) summary for premarket notification K942196 for the device identified as the Diascope NT indicates that the original display is monochrome with only four grey tones.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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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