FDA 510(k)

KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II

K-Number: K983626 · 1999-02-05

Decision Date1999-02-05

Product CodeDXH

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II is the device name listed in this FDA 510(k) record. The listed applicant is Alaris Medical Systems, Inc.. It received FDA 510(k) clearance on 1999-02-05 under 510(k) number K983626. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II?

KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II is a medical device that received FDA 510(k) clearance on 1999-02-05. The listed applicant is Alaris Medical Systems, Inc.. The 510(k) number is K983626.

When did KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II receive FDA 510(k) clearance?

KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II received FDA 510(k) clearance on 1999-02-05, under 510(k) number K983626.

Who is the listed applicant for KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II?

The FDA 510(k) record lists Alaris Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II?

The FDA product code for KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II is DXH. This falls under the Hematology category.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Alaris Medical Systems, Inc. as applicant

K043299MEDLEY PCA MODULE, MODEL 8120 K041241MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600 K031741MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300 K032233MEDLEY PCA MODULE, MODEL 8120 K032147SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES K030459MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS)

View all 16 devices →

Related Devices (Code: DXH)

K250233PreemptiveAI Clinical SDKMeasure Labs, Inc. (Dba Preemptiveai, Inc.)K250258HeartBeam AIMIGo with 12-L ECG Synthesis Software SystemHeartbeam, Inc.K243438MEMO Patch M (MPT-E08R-UNC01)Huinno Co., Ltd.K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.K243003VitalSigns 1-Lead Holter (VSH101)VitalSigns Technology Co., Ltd.K233521QT ECG (QTERD100)QT Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.