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510(k) K211822

LifePath Remote Patient Monitoring Platform by Elastic Care Incorporated — Product Code DRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 2022
Date Received
June 14, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class
Class II
Regulation Number
870.2910
Review Panel
CV
Submission Type

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