510(k) K181196

Caretaker Remote Display App and Caretaker Software Library by Caretaker Medical, LLC — Product Code DRG

K181196 is an FDA 510(k) premarket notification submitted by Caretaker Medical, LLC for the device "Caretaker Remote Display App and Caretaker Software Library". The FDA issued a decision of Substantially Equivalent on October 3, 2018. The device falls under product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency), a Class II device regulated under 21 CFR 870.2910. Caretaker Medical, LLC has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2018
Date Received
May 7, 2018
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