READMYHEART, MODEL RMH3.0— 510(k) K050620

Name: FDA 510(k) clearance K050620
Creator: U.S. Food and Drug Administration
Published: 2005-07-14

Substantially Equivalent

Dailycare Biomedical, Inc.

FDA 510(k) clearance K050620 for READMYHEART, MODEL RMH3.0, Substantially Equivalent on 2005-07-14. Applicant: Dailycare Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: Dailycare Biomedical, Inc.
Product code: Code DPS
Device class: Class 2
Regulation: 21 CFR 870.2340
Advisory panel: Cardiovascular
Date received: 2005-03-10
Decision date: 2005-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chungli, TW

Download summary PDF View on FDA.gov ↗

Recent devices under product code DPS

view all

K252463 — SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)2026-07-02
K251670 — MAC 7 Resting ECG Analysis System2026-01-26
K252361 — AccurECG Analysis System (v2.0)2025-12-22
K252474 — Withings BeamO (SCT02)2025-11-10
K250569 — Cardiologs Holter Platform2025-08-06

More clearances from Dailycare Biomedical, Inc.

view all

K172778 — CheckMyHeart Plus2018-07-05
K062894 — INSTANTCHECK RTD-ECG MONITOR, MODEL RMH4.02007-02-08
K052303 — READMYHEART, MODEL RMH2.02005-12-16
K042814 — READMYHEART2005-01-06

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.