← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

DRG — Transmitters And Receivers, Physiological Signal, Radiofrequency

DEVICE CLASS
Class II
REGULATION
21 CFR 870.2910
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
7
510(K)/PMA CLEARANCES
510k: 7
0
RECALL ENTRIES

Recent clearances

K261569Lifesignals, Inc. · 510k2026-07-09
K252984Perin Health Devices, LLC · 510k2026-01-22
K252440Ingeniars S.R.L. · 510k2025-10-02
K250259The ScottCare Corporation · 510k2025-06-04
K243837Iorbit Digital Technologies Private Limited · 510k2025-05-16
K242018Lifesignals, Inc. · 510k2024-11-12
K241101Biointellisense, Inc. · 510k2024-09-26

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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