510(k) K202868

LifeSignals Multi-Parameter Remote Monitoring Platform by Lifesignals, Inc. — Product Code DRG

K202868 is an FDA 510(k) premarket notification submitted by Lifesignals, Inc. for the device "LifeSignals Multi-Parameter Remote Monitoring Platform". The FDA issued a decision of Substantially Equivalent on July 21, 2021. The device falls under product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency), a Class II device regulated under 21 CFR 870.2910. Lifesignals, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2021
Date Received
September 28, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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