PATIENT DATA HANDLER & DEVICES (PDH&D)— 510(k) K063484

Name: FDA 510(k) clearance K063484
Creator: U.S. Food and Drug Administration
Published: 2006-12-22

Substantially Equivalent

Intermed Advisors, Inc.

FDA 510(k) clearance K063484 for PATIENT DATA HANDLER & DEVICES (PDH&D), Substantially Equivalent on 2006-12-22. Applicant: Intermed Advisors, Inc.. Device class: 2.

Clearance details

Applicant: Intermed Advisors, Inc.
Product code: Code DRG
Device class: Class 2
Regulation: 21 CFR 870.2910
Advisory panel: Cardiovascular
Date received: 2006-11-17
Decision date: 2006-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DRG

view all

K261569 — UbiqVue 2AYe Cardiac System (UX2253)2026-07-09
K252984 — Perin Health System (PHD80060-2)2026-01-22
K252440 — EasyTeleMed (2.0.2)2025-10-02
K250259 — TeleRehab Aermos Cardiopulmonary Rehabilitation2025-06-04
K243837 — iBSM2025-05-16

Adverse events under product code DRG

product code DRG

Death: 5
Total: 5

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.