← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

DXH — Transmitters And Receivers, Electrocardiograph, Telephone

DEVICE CLASS
Class II
REGULATION
21 CFR 870.2920
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
5
510(K)/PMA CLEARANCES
510k: 5
0
RECALL ENTRIES

Recent clearances

K250233Measure Labs, Inc. (Dba Preemptiveai, Inc.) · 510k2026-02-13
K250258Heartbeam, Inc. · 510k2025-12-08
K243438Huinno Co., Ltd. · 510k2025-12-05
K243981Carre Technologies, Inc. · 510k2025-11-18
K243003VitalSigns Technology Co., Ltd. · 510k2025-06-17

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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