FDA.reportPublic FDA data

ADVANCED PATIENT MONITOR

Primary DI
B510PM2000TM1
Brand
ADVANCED PATIENT MONITOR
Company
ADVANCED INSTRUMENTATIONS, INC.
Model
PM-2000TM
Published
2020-04-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
CBQAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
CBRAnalyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
DQAOximeter
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
DSACable, Transducer And Electrode, Patient, (Including Connector)
DSIDetector And Alarm, Arrhythmia
DSKComputer, Blood-Pressure
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
FLLThermometer, Electronic, Clinical
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
MLDMonitor, St Segment With Alarm

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBQAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)Anesthesiology2
CBRAnalyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)Anesthesiology2
CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)Anesthesiology2
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2
CCLAnalyzer, Gas, Oxygen, Gaseous-PhaseAnesthesiology2
DQAOximeterCardiovascular2
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)Cardiovascular2
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2
DSIDetector And Alarm, ArrhythmiaCardiovascular2
DSKComputer, Blood-PressureCardiovascular2
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2
FLLContinuous Measurement ThermometerGeneral Hospital2
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2
MLDMonitor, St Segment With AlarmCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132077000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132077000PATIENT MONITORAdvanced Instrumentations, Inc.2014-04-23MHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B510PM2000TM1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, multifunctionA small unit dedicated to the measurement and displays of several physiological parameters, e.g., electrical activity of the heart, respiratory rate, temperature, blood pressure, pulse, and oximetry. The signals are obtained through connected cables/leads/probes. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device which then operates as a mainframe computer displaying the various parameters/information measured and provided by this module.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
608736880
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B510SL700700LED1ADVANCED SURGICAL LAMP SL700/700 LED2026-03-24
D510DUS6000ADVANCED DIGITAL PORTABLE ULTRASONIC SYSTEM DUS-60002026-03-24
B510D100ADVANCED MONITOR DEFIBRILLATORD100+2026-01-14
B510PT3000ADVANCED PHOTOTHERAPY LAMP PT-30002025-08-21
B510PM200MPRO1ADVANCED PATIENT MONITORPM-200M PRO2025-07-23
B510V1000ADVANCED VENTILATORV-10002025-02-10
B510A31860ADVANCED NEONATAL INCUBATORA31862025-02-07
B510A31861ADVANCED NEONATAL INCUBATORA3186+2025-02-07
B510A4051ADVANCED INFANT WARMERA40512025-02-07
B510AM60001ADVANCED GAS-MACHINE ANESTHESIAAM-6000+2025-02-07
B510FM9000ADVANCED FETAL MONITORFM-90002025-02-07
B510PT2000ADVANCED LED PHOTOTHERAPY LAMPPT-20002025-02-07
B510PT5000ADVANCED LED PHOTOTHERAPY LAMPPT-50002025-02-07
B510A3158ADVANCED TRANSPORT INCUBATORA31582025-02-04
B510IP200ADVANCED INFUSION PUMPIP-2002025-02-04
B510PMMAX13ADVANCED PATIENT MONITORPM-Max132024-12-19
B510PMMAX15ADVANCED PATIENT MONITORPM-Max152024-12-19
B510PM2000A1ADVANCED PATIENT MONITORPM-2000A2020-04-16
B510PM2000APRO1ADVANCED PATIENT MONITORPM-2000A PRO2020-04-16
B510PM2000M1ADVANCED PATIENT MONITORPM-2000M2020-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946725538005APKAPK Technology Co.,Ltd.DQA2026-09-04
06946725548998APKAPK Technology Co.,Ltd.DQA2026-09-04
06946725572276APKAPK Technology Co.,Ltd.DQA2026-09-04
03700506301775INTEGRAL PROCESS Cables & LeadwiresNISSHA MEDICAL TECHNOLOGIES SASDSA2026-08-27
04036616011983Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-27
06920485308580P PANACAREShenzhen BSX Technology Electronics Co., Ltd.DXN2026-08-26
06944413835153Telemetry MonitorEdan Instruments, Inc.FLL2026-08-26
06944413835153Telemetry MonitorEdan Instruments, Inc.MHX2026-08-26
06944413835153Telemetry MonitorEdan Instruments, Inc.DQA2026-08-26
06944413835153Telemetry MonitorEdan Instruments, Inc.DRT2026-08-26
06944413835153Telemetry MonitorEdan Instruments, Inc.DXN2026-08-26
06944413835153Telemetry MonitorEdan Instruments, Inc.MLD2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.MHX2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DQA2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DRT2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.MLD2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.FLL2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DXN2026-08-26
10889483618264Air LifeAIRLIFECCK2026-08-26
10889483618271Air LifeAIRLIFECCK2026-08-26
10889483618288Air LifeAIRLIFECCK2026-08-26
10889483618295Air LifeAIRLIFECCK2026-08-26
10889483618301Air LifeAIRLIFECCK2026-08-26
10889483618318Air LifeAIRLIFECCK2026-08-26
00634782101633Diagnostix™AMERICAN DIAGNOSTIC CORPDQA2026-08-25
00634782102265Advantage™AMERICAN DIAGNOSTIC CORPDXN2026-08-25
00810226442306ViveVIVE HEALTH LLCDXN2026-08-25
G662ME590032R1MaguireMaguire Enterprises, Inc.DSA2026-08-25
00856324008778PARAMEDSILEX GLOBAL LLCDXN2026-08-22
06971522821753LineshareShenzhen Finicare Co., LtdDXN2026-08-22