HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor M3000A/M3046A/M3016A,REL B

FDA 510(k) K992273 · Hewlett-Packard GmbH

Substantially Equivalent

510(k) numberK992273

Submission

Device name
HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor M3000A/M3046A/M3016A,REL B
Applicant
Hewlett-Packard GmbH
Boeblingen, DE
Received
July 7, 1999
Decision date
January 28, 2000
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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K992543Heartstream XLT Defibrillator/Monitor, Ac Charger, DC Charger, Data Card, Single Bay…MKJ · Traditional 05/18/2000SE
K993383HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor Models M3000A…DSI · Abbreviated 02/03/2000SE
K993587HP M2376A Device Link SystemMQS · Traditional 01/20/2000SE
K993169Modification of: Physiological Signal Transmitter and Receiver, Model 3810ADRG · Traditional 12/20/1999SE
K992595HP Viridia Component Monitoring System, Model Rev. K with Easi-St Segment Measurement…MHX · Special 12/08/1999SE
K992977Hewlett Packard Multifunction Pediatric Defib Function, Model M3503A & M3504AMKJ · Traditional 12/01/1999SE
K993516HP M2600A Viridia Telemetry SystemDSI · Special 11/08/1999SE
K992674HP Viridia CMS Patient Monitor with EEG Parameter, Model M1027AMHX · Abbreviated 11/08/1999SE
K993171HP Viridia Information System, Models M3150A/ M3151A/ M3153A/ M3154ADSI · Special 10/21/1999SE
K992636HP Carevue 9000 Clinical Information System, Model M2331ADXJ · Special 08/31/1999SE

Questions and answers

When was HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor M3000A/M3046A/M3016A,REL B cleared by the FDA?

HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor M3000A/M3046A/M3016A,REL B (K992273) received a 510(k) decision of Substantially Equivalent on January 28, 2000, 205 days after the submission was received.

What is the product code of K992273?

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.