Home / 510(k) Clearances / K062894

510(k) K062894

INSTANTCHECK RTD-ECG MONITOR, MODEL RMH4.0 by Dailycare Biomedical, Inc. — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2007
Date Received
September 27, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph
Device Class
Class II
Regulation Number
870.2340
Review Panel
CV
Submission Type

Other clearances by Dailycare Biomedical, Inc.

  • K172778 — CheckMyHeart Plus (July 5, 2018)
  • K052303 — READMYHEART, MODEL RMH2.0 (December 16, 2005)
  • K050620 — READMYHEART, MODEL RMH3.0 (July 14, 2005)
  • K042814 — READMYHEART (January 6, 2005)

Other clearances for product code DPS

  • K251670 — MAC 7 Resting ECG Analysis System (January 26, 2026)
  • K252361 — AccurECG Analysis System (v2.0) (December 22, 2025)
  • K252474 — Withings BeamO (SCT02) (November 10, 2025)
  • K250569 — Cardiologs Holter Platform (August 6, 2025)
  • K243252 — ZBPro Diagnostic (July 10, 2025)
  • K243305 — Masimo W1 (April 3, 2025)
  • K241217 — CloudHRV™ System (100-01-001) (January 16, 2025)
  • K241556 — Cardiac Workstation (5000); Cardiac Workstation (7000) (December 17, 2024)
  • K240229 — Masimo W1 (August 8, 2024)
  • K232161 — DeepRhythm Platform (June 20, 2024)