Day

June 17, 1998
6/17/98 Lifescan Surestep Blood Glucose Monitoring System (Meter of home use) Changed to Class I 727,004 units The meters may give an Er 1 (Error 1)message if a patient’s blood glucose is 500 mg/dL or greater.
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Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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