17
Jun
1998

004 units Lifescan Glucose Meter Class I 727

0

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.

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.

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