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510(k) K983626

KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II by Alaris Medical Systems, Inc. — Product Code DXH

K983626 is an FDA 510(k) premarket notification submitted by Alaris Medical Systems, Inc. for the device "KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II". The FDA issued a decision of Substantially Equivalent on Feb 5, 1999. The device falls under product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone), a Class II device regulated under 21 CFR 870.2920. Alaris Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 5, 1999
Date Received
Oct 15, 1998
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Device Class
Class II
Regulation Number
870.2920
Review Panel
CV
Submission Type

Other clearances by Alaris Medical Systems, Inc.

  • K043299 — MEDLEY PCA MODULE, MODEL 8120 (Dec 10, 2004)
  • K041241 — MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600 (Jul 6, 2004)
  • K031741 — MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300 (Feb 9, 2004)
  • K032233 — MEDLEY PCA MODULE, MODEL 8120 (Sep 9, 2003)
  • K032147 — SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 7 (Jul 25, 2003)
  • K030459 — MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS) (Apr 4, 2003)
  • K023264 — MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110 (Dec 19, 2002)
  • K022677 — MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE (Sep 11, 2002)
  • K022209 — ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS (Aug 6, 2002)
  • K013087 — SINGLE DOSE DISPENSING PIN, MODEL 2201 (Nov 13, 2001)

Other clearances for product code DXH

  • K250233 — PreemptiveAI Clinical SDK (Feb 13, 2026)
  • K250258 — HeartBeam AIMIGo with 12-L ECG Synthesis Software System (Dec 8, 2025)
  • K243438 — MEMO Patch M (MPT-E08R-UNC01) (Dec 5, 2025)
  • K243981 — Hexoskin Medical System (7100-00016) (Nov 18, 2025)
  • K243003 — VitalSigns 1-Lead Holter (VSH101) (Jun 17, 2025)
  • K233521 — QT ECG (QTERD100) (Dec 6, 2023)
  • K222842 — V-Patch Cardiac Monitor (Oct 20, 2022)
  • K220795 — QT ECG (Sep 26, 2022)
  • K213357 — Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Puls (Jul 19, 2022)
  • K220350 — KardiaMobile 6L (May 25, 2022)

FDA data resources