HP Viridia CMS Patient Monitor with EEG Parameter, Model M1027A

Q: What is the product code of K992674?

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) K992674 · Hewlett-Packard GmbH

Substantially Equivalent

510(k) numberK992674

Submission

Device name: HP Viridia CMS Patient Monitor with EEG Parameter, Model M1027A
Applicant: Hewlett-Packard GmbH
Boeblingen, DE
Received: August 10, 1999
Decision date: November 8, 1999
Decision: Substantially Equivalent (SESE)
Type: Abbreviated 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

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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
K992543	Heartstream XLT Defibrillator/Monitor, Ac Charger, DC Charger, Data Card, Single Bay…MKJ · Traditional	05/18/2000SE
K993383	HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor Models M3000A…DSI · Abbreviated	02/03/2000SE
K992273	HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor…MHX · Abbreviated	01/28/2000SE
K993587	HP M2376A Device Link SystemMQS · Traditional	01/20/2000SE
K993169	Modification of: Physiological Signal Transmitter and Receiver, Model 3810ADRG · Traditional	12/20/1999SE
K992595	HP Viridia Component Monitoring System, Model Rev. K with Easi-St Segment Measurement…MHX · Special	12/08/1999SE
K992977	Hewlett Packard Multifunction Pediatric Defib Function, Model M3503A & M3504AMKJ · Traditional	12/01/1999SE
K993516	HP M2600A Viridia Telemetry SystemDSI · Special	11/08/1999SE
K993171	HP Viridia Information System, Models M3150A/ M3151A/ M3153A/ M3154ADSI · Special	10/21/1999SE
K992636	HP Carevue 9000 Clinical Information System, Model M2331ADXJ · Special	08/31/1999SE

Questions and answers

When was HP Viridia CMS Patient Monitor with EEG Parameter, Model M1027A cleared by the FDA?

HP Viridia CMS Patient Monitor with EEG Parameter, Model M1027A (K992674) received a 510(k) decision of Substantially Equivalent on November 8, 1999, 90 days after the submission was received.

What is the product code of K992674?

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.