← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
MHX — Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
DEVICE CLASS
Class II
REGULATION
21 CFR 870.1025
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
16
510(K)/PMA CLEARANCES
510k: 16
0
RECALL ENTRIES
Recent clearances
K254209Masimo Corporation · 510k2026-06-04
K252840Global Instrumentation, LLC · 510k2026-05-29
K260098Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 510k2026-05-20
K250349Shanghai Draeger Medical Instrument Co., Ltd. · 510k2026-04-24
K253170Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 510k2026-04-16
K252250Shanghai Draeger Medical Instrument Co., Ltd. · 510k2026-04-10
K252726Philips Medizin Systeme Boeblingen GmbH · 510k2026-02-06
K252589AliveCor, Inc. · 510k2026-01-09
Related on SPEQ
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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