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510(k) K050620

READMYHEART, MODEL RMH3.0 by Dailycare Biomedical, Inc. — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2005
Date Received
March 10, 2005
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)
  • K062894 — INSTANTCHECK RTD-ECG MONITOR, MODEL RMH4.0 (February 8, 2007)
  • K052303 — READMYHEART, MODEL RMH2.0 (December 16, 2005)
  • K042814 — READMYHEART (January 6, 2005)

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