FDA.reportPublic FDA data

Patient Monitor

Primary DI
06932562310133
Brand
Patient Monitor
Company
Guangdong Biolight Meditech Co., Ltd.
Model
M8000A
Device description
The Monitor is used to monitor patient’s physiological parameters such as ECG、Respiration Rate( RESP)、Oxygen Saturation (BLT-SpO2)、Non-invasive Blood Pressure (NIBP)、Invasive Blood Pressure( IBP)、Temperature (TEMP)、Carbon dioxide (CO2) 、Anesthetic Gas (AG )and Impedance Cardiograph (ICG) continuously
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100046000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100046000M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000Guangdong Biolight Meditech Co., Ltd.2010-04-08MHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06932562310133PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06932562310133069325623101336932562310133

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
530120146
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06932562310355Fingertip Pluse OximeterM70D2024-03-29
06932562310362handheld monitorM8002024-03-29
06932562310263Fetal monitorF302018-04-09
06932562310270Fetal monitorF502018-04-09
06932562310287Fetal monitorF802018-04-09
06932562310294Fetal monitorF902018-04-09
06932562310317 Fingertip Pulse OximeterM502019-08-28
06932562310324 Fingertip Pulse OximeterM50L2019-08-28
06932562310348Fingertip Pulse OximeterM50A2021-06-28
06932562310331patient monitorM90002020-08-10
06932562310300Vital Signs MonitorV92019-07-03
06932562310003Fingertip Pluse OximterM702016-09-07
06932562310010Fingertip Pluse OximeterM70A2016-09-20
06932562310027Fingertip Pluse OximeterM70C2016-09-13
06932562310058Handheld Pulse MonitorM8002016-09-22
06932562310065Handheld Pulse OximeterM7002016-09-22
06932562310089Patient MonitorQ52016-09-22
06932562310096Patient MonitorQ52016-09-22
06932562310102Patient MonitorM85002016-09-22
06932562310119Patient MonitorM95002016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195278490742VSPGe Medical Systems Information Technologies, Inc.MHX2026-11-03
04048675786320Infinity M540DRAEGER MEDICAL SYSTEMS, INC.MHX2026-10-26
00884838085299Dual IBP AdapterPhilips Medizin Systeme Böblingen GmbHMHX2026-10-21
00884838102866Telemetry Monitor 5500Philips Medizin Systeme Böblingen GmbHMHX2026-10-15
06944413809468Connection CableEdan Instruments, Inc.MHX2026-10-15
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyMHX2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyMHX2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyMHX2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyMHX2026-10-04
04538612061813FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612061820FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612230837FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612230844FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916229FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916632FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916649FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916656FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916663FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916670FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916687FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916694FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
06944413835153Telemetry MonitorEdan Instruments, Inc.MHX2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.MHX2026-08-26
B353UB25511UbiqVue MultiparameterLifesignals, Inc.MHX2026-07-20
04538612151569FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-07-17
04538612161049FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-07-17
04538612209543FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-07-17
04538612226113FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-07-17
04538612226922FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-07-17
04538612228070FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-07-17