K252685

Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P)

510(k) number: K252685
Device name: Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P)
Applicant: Joytech Healthcare Co. , Ltd. CN
Product code: DXN — System, Measurement, Blood-Pressure, Non-Invasive
Decision date: 2026-02-13
Date received: 2025-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Cardiovascular

510(k) Summary (official FDA PDF): K252685.pdf

Official FDA record: K252685

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.