510(k) K242528

Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK266, RAK268, RAK269, RAK282, RAK283, RAK286, RAK288, RAK289, RAK291, RAK292, RAK293, RAK295, RAK296, RAK297, RAK298) by Shenzhen Ruiankang Technology Co., Ltd. — Product Code DXN

K242528 is an FDA 510(k) premarket notification submitted by Shenzhen Ruiankang Technology Co., Ltd. for the device "Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK266, RAK268, RAK269, RAK282, RAK283, RAK286, RAK288, RAK289, RAK291, RAK292, RAK293, RAK295, RAK296, RAK297, RAK298)". The FDA issued a decision of Substantially Equivalent on January 10, 2025. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2025
Date Received
August 26, 2024
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