Calysto Series IV Patient Care Monitors and Central Station and ECG Management System

Q: What is the product code of K033030?

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) K033030 · Witt Biomedical Corp

Substantially Equivalent

510(k) numberK033030

Submission

Device name: Calysto Series IV Patient Care Monitors and Central Station and ECG Management System
Applicant: Witt Biomedical Corp
Melbourne, FL, US
Received: September 26, 2003
Decision date: February 24, 2004
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement 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
K101571	Xper Information Management and Flex Cardio Physiomonitoring SystemsMWI · Traditional	10/26/2010SE
K063840	Xper Information Management/Physiomonitoring 5 System And/Or Vascular 5, Patient Care…MWI · Traditional	02/06/2007SE
K063547	Calysto Series IV Physio-Monitoring and Information SystemMWI · Special	12/21/2006SE
K040195	Calysto Image Iv-Image and Information Management SystemLLZ · Traditional	04/07/2004SE
K010058	Image IV Dicom Image Archival Pacs NetworkLLZ · Traditional	03/21/2001SE
K973474	Witt Biomedical Central Station Monitoring System and Witt Biomedical Advanced Patient…MHX · Traditional	03/13/1998SE
K950436	Witt Biomedical Series IVMHX · Traditional	11/02/1995SE
K945582	Witt Biomedical Image IIILLZ · Traditional	06/19/1995SE
K923054	Witt Biomedical Series Ii-EpMHX · Traditional	02/25/1993SE
K880258	Witt Biomedical VX-80DXG · Traditional	06/16/1988SE

Questions and answers

When was Calysto Series IV Patient Care Monitors and Central Station and ECG Management System cleared by the FDA?

Calysto Series IV Patient Care Monitors and Central Station and ECG Management System (K033030) received a 510(k) decision of Substantially Equivalent on February 24, 2004, 151 days after the submission was received.

What is the product code of K033030?

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.