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510(k) K012226

Device
MONITORING SYSTEM,MODEL ARGUS PB-1000
Applicant
SCHILLER AG
510(k) number
K012226
Product code
MHX  
Decision
Substantially Equivalent (SESE)
Decision date
2002-04-08
Date received
2001-07-16
Regulation
870.1025
Classification name
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MARKUS BUETLER
Address
Altgasse 68 Baar CH CH-6341 CH-6341

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MHX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland Oy2026-08-28
K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.2026-08-20
K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.2026-08-06
K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.2026-07-24
K254209Radius VSM and AccessoriesMasimo Corporation2026-06-04
K252840M12 Telemetry SystemGlobal Instrumentation, LLC2026-05-29
K260098ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2026-05-20
K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.2026-04-24
K253170uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient MonitorsShenzhen Mindray Bio-Medical Electronics Co., Ltd.2026-04-16
K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427)Shanghai Draeger Medical Instrument Co., Ltd.2026-04-10
K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036)Philips Medizin Systeme Boeblingen GmbH2026-02-06
K252589Corvair MonzaAliveCor, Inc.2026-01-09
K250854Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro)Shenzhen Comen Medical Instruments Co.,Ltd2025-12-17
K251702IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 )Philips Medizin Systeme Böblingen GmbH2025-11-10
K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH2025-10-17

Legacy Summary#

summary

FDA Review#

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