Mckesson Cardiology Hemo

Q: What is the product code of K131497?

The FDA product code is MWI – Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), a Class II (moderate risk) device regulated under 21 CFR 870.2300.

FDA 510(k) K131497 · Mckesson Israel , Ltd.

Substantially Equivalent

510(k) numberK131497

Submission

Device name: Mckesson Cardiology Hemo
Applicant: Mckesson Israel , Ltd.
Alpharetta, GA, US
Received: May 24, 2013
Decision date: December 5, 2013
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: MWI – Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.2300
Specialty: Cardiovascular

Other 510(k)s with product code MWI

510(k)	Device	Applicant	Decision
K260438	Vital Signs Monitor (CLEO2)MWI · Traditional	Infinium Medical, Inc.	08/14/2026SE
K253417	Masimo Root Monitoring SystemMWI · Traditional	Masimo Corporation	08/12/2026SE
K253196	Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)MWI · Traditional	Midmark Corporation	06/12/2026SE
K253436	c-med0 alphaMWI · Traditional	Cosinuss GmbH	04/30/2026SE
K250135	WAVE Clinical Platform (2.0.000)MWI · Traditional	Baxter Healthcare Corp/ Excel Medical	01/16/2026SE
K241766	QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)MWI · Traditional	Fysicon BV	08/27/2025SE
K242737	Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalMWI · Traditional	Empatica S.r.l.	06/06/2025SE
K241958	WARD-CSS (v1.2.x)MWI · Traditional	Ward 24/7 Aps	02/14/2025SE
K243146	iCare APPMWI · Traditional	Ihealth Labs, Inc.	02/03/2025SE
K241411	Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)MWI · Traditional	Welch Allyn, Inc.	12/20/2024SE

More from Welch Allyn, Inc.

510(k)	Device	Decision
K151850	McKesson CardiologyLLZ · Traditional	08/11/2015SE
K133534	Mckesson Cardiology ECG MobileDQK · Traditional	04/18/2014SE
K113515	Horizon Cardiology ECG ManagementDQK · Traditional	03/16/2012SE
K112720	Mckesson Horizon CardiologyLLZ · Traditional	01/30/2012SE

Questions and answers

When was Mckesson Cardiology Hemo cleared by the FDA?

Mckesson Cardiology Hemo (K131497) received a 510(k) decision of Substantially Equivalent on December 5, 2013, 195 days after the submission was received.

What is the product code of K131497?

The FDA product code is MWI – Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), a Class II (moderate risk) device regulated under 21 CFR 870.2300.