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FDA PRODUCT CODE · CLASS II

DPS — Electrocardiograph

DEVICE CLASS
Class II
REGULATION
21 CFR 870.2340
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
9
510(K)/PMA CLEARANCES
510k: 9
0
RECALL ENTRIES

Recent clearances

K252463Edan Instruments, Inc. · 510k2026-07-02
K251670Ge Medical Systems Information Technologies, Inc. · 510k2026-01-26
K252361Accurkardia, Inc. · 510k2025-12-22
K252474Withings · 510k2025-11-10
K250569Philips France Commercial · 510k2025-08-06
K243252Zbeats, Inc. · 510k2025-07-10
K243305Masimo Corporation · 510k2025-04-03
K241217Inmedix, Inc. · 510k2025-01-16

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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