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510(k) K213699

CareTaker Monitor App by Caretaker Medical, LLC — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2022
Date Received
November 23, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
Review Panel
CV
Submission Type

Other clearances by Caretaker Medical, LLC

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  • K211588 — Caretaker Platform, VitalStream Platform, CT5 (August 13, 2021)
  • K181196 — Caretaker Remote Display App and Caretaker Software Library (October 3, 2018)
  • K163255 — CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vit (April 21, 2017)
  • K151499 — CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VIt (March 18, 2016)

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  • K253133 — Wrist Blood Pressure Monitor (BPM-W1VL) (February 13, 2026)
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  • K251143 — Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L) (December 19, 2025)
  • K251331 — Blood Pressure Monitor (B73, BE23T) (October 27, 2025)
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