← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

DXN — System, Measurement, Blood-Pressure, Non-Invasive

DEVICE CLASS
Class II
REGULATION
21 CFR 870.1130
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
53
510(K)/PMA CLEARANCES
510k: 53
0
RECALL ENTRIES

Recent clearances

K253126Shenzhen Ziqing Medical Equipment Co., Ltd. · 510k2026-06-18
K26069380 Beats Medical GmbH · 510k2026-06-16
K253059Tournicare Pty, Ltd. · 510k2026-06-15
K253124Shenzhen Ziqing Medical Equipment Co., Ltd. · 510k2026-06-03
K253570Shenzhen Jamr Technology Co., Ltd. · 510k2026-05-20
K254048Shenzhen Urion Technology Co., Ltd. · 510k2026-05-14
K253152Biozen, LLC · 510k2026-05-06
K252501Joytech Healthcare Co. , Ltd. · 510k2026-04-28

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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