510(k) number: BK180200 Applicant: Mediware Information Systems, Inc. Device Name: LifeTrak®2018 Decision Date: 7/3/2018
Supporting Documents
BK180200 Letter
The original posted letter has been replaced with a revised letter to add the regulation name and CFR, and to change the dated/received dates.
BK180200 Summary
The original posted summary has been replaced with a revised summary to update the Classification name.