Spacelabs Healthcare Xprezzon Beside MONITOR(9913930)

Q: What is the product code of K112962?

The FDA product code is MHX – Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), a Class II (moderate risk) device regulated under 21 CFR 870.1025.

FDA 510(k) K112962 · Spacelabs Medical, Inc.

Substantially Equivalent

510(k) numberK112962

Submission

Device name: Spacelabs Healthcare Xprezzon Beside MONITOR(9913930)
Applicant: Spacelabs Medical, Inc.
Issaquah, WA, US
Received: October 5, 2011
Decision date: November 2, 2011
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: MHX – Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.1025
Specialty: Cardiovascular

Other 510(k)s with product code MHX

510(k)	Device	Applicant	Decision
K260656	Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP…MHX · Traditional	GE Healthcare Finland Oy	09/01/2026SE
K260343	Carescape Canvas 1000; Carescape Canvas Smart DisplayMHX · Traditional	GE Healthcare Finland Oy	08/28/2026SE
K260579	Infinity® Acute Care System (IACS) VG8.1MHX · Traditional	Draeger Medical Systems, Inc.	08/20/2026SE
K251508	Telemetry Monitor (iT30, iT50)MHX · Traditional	Edan Instruments, Inc.	08/06/2026SE
K253277	Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PMHX · Traditional	Ge Medical Systems Information Technologies, Inc.	07/24/2026SE
K254209	Radius VSM and AccessoriesMHX · Traditional	Masimo Corporation	06/04/2026SE
K252840	M12 Telemetry SystemMHX · Traditional	Global Instrumentation, LLC	05/29/2026SE
K260098	ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C…MHX · Traditional	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	05/20/2026SE
K250349	Vista CMSMHX · Traditional	Shanghai Draeger Medical Instrument Co., Ltd.	04/24/2026SE
K253170	uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient MonitorsMHX · Traditional	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	04/16/2026SE

More from Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

510(k)	Device	Decision
K120616	Spacelabs Healthcare Qube Compact Monitor (91390MHX · Special	03/29/2012SE
K102422	Spacelabs Medical Patient MonitorsMHX · Special	12/07/2010SE
K093501	Elance Vital Signs Monitor and Elance Central StationMHX · Special	11/24/2009SE
K082045	Modification to Mcare 300 Vital Signs Monitor, Model 91220MHX · Special	08/01/2008SE
K063490	Spacelabs Medical Full Disclosure System, Model 91810DQK · Traditional	03/15/2007SE
K062095	Mcare 300 Vital Signs Monitor, Model 91220MHX · Abbreviated	09/29/2006SE
K062278	Spacelabs Medical Clinical Event Interface, Model 91847MSX · Special	09/19/2006SE
K060900	Spacelabs Medical Bispectral Index (Bisx) Analysis Module 91482 and Accessories…OLW · Traditional	06/23/2006SE
K053599	Spacelabs Medical Multigas Analyzer Module 91518 and AccessoriesCBR · Special	04/19/2006SE
K050605	Spacelabs Medical Multiparameter Module 91496DSI · Special	05/03/2005SE

Questions and answers

When was Spacelabs Healthcare Xprezzon Beside MONITOR(9913930) cleared by the FDA?

Spacelabs Healthcare Xprezzon Beside MONITOR(9913930) (K112962) received a 510(k) decision of Substantially Equivalent on November 2, 2011, 28 days after the submission was received.

What is the product code of K112962?

The FDA product code is MHX – Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), a Class II (moderate risk) device regulated under 21 CFR 870.1025.