FDA.reportPublic FDA data

PS410

Primary DI
00850540007171
Brand
PS410
Company
FLUKE ELECTRONICS CORPORATION
Model
PS410
Catalog number
2631276
Device description
Patient Simulator
Published
2018-05-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DPSElectrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K963198000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K963198000PS-41 6M PATIENT SIMULATORMetron U.S., Inc.1997-03-05DPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850540007171PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850540007171008505400071718505400071710850540007171

GMDN Terms#

Term, Definition table
TermDefinition
Multi-parameter device testerA battery-powered electronic device designed to measure two or more parameters (e.g., temperature, conductivity, pressure, pH, flow) to calibrate or test a medical device (e.g., haemodialysis equipment, anaesthesia machine, suction system, ophthalmic laser). It typically consists of a hand-held electronic box with appropriate connections and a digital display; dedicated measuring devices (e.g., probe, sensor, electrode, buffer solution) are typically included. It is not dedicated to a specific clinical discipline and is intended to be used by a professional in a professional setting (e.g., clinical engineering).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
002687614
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850540007133Impulse 4000IMPULSE4K-USA120V22471572018-05-24
00850540007157SigmaPace 1000SIGMAP1K-USA120V22477002018-05-24
00850540007188DPM1BDPM1B22497792018-05-24
00850540007225ProSim 8PPROSIM 8P60217062025-05-07
00850540007195BP Pump 2LBPPUMP2L-US120V22490362018-05-24
00850540007201BP Pump 2MBPPUMP2M-US120V22490492018-05-24
00850540007218ESA 614ESA61450319182019-04-04
00850540007065ProSim 8PROSIM 839794092018-05-24
00850540007072ProSim 4PROSIM 439851562018-05-24
00850540007089ProSim 2PROSIM 243183412018-05-24
00850540007096ProSim 3PROSIM 343077902018-05-24
00850540007102ProSim SPOT LightSPOT LIGHT41111012018-05-24
00850540007119Impulse 6000DIMPULSE 6000D28119282018-05-24
00850540007140Impulse 7010IMPULSE 701031585442018-05-24
00850540007164PS320PS32025830302018-05-24
00850540007010ESA 620ESA62027857252018-05-24
00850540007027ESA 615ESA615-US41320462018-05-24
00850540007034ESA 615ESA615-10-NA22041321642018-05-24
00850540007041ESA 612ESA612-US41321732018-05-24
00850540007058ESA 612ESA612-10-NA22041322602018-05-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011800613CardioTagCARDIOSENSE, INC.DPS2026-10-14
00195278840202MACGe Medical Systems Information Technologies, Inc.DPS2026-10-13
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyDPS2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyDPS2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyDPS2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyDPS2026-10-04
00810209880118CORE 500 Digital Stethoscope - Lilac ChestpieceEko Health, Inc.DPS2026-10-01
00810209880163CORE 500 Digital Stethoscope FIGS Earpiece - EspressoEko Health, Inc.DPS2026-10-01
00810209880170CORE 500 Digital Stethoscope FIGS Earpiece - Ruby RedEko Health, Inc.DPS2026-10-01
00810209880187CORE 500 Digital Stethoscope - Ember ChestpieceEko Health, Inc.DPS2026-10-01
06944413835153Telemetry MonitorEdan Instruments, Inc.DPS2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DPS2026-08-26
00884838096738Cardiac WorkstationPhilips Medizin Systeme Böblingen GmbHDPS2026-08-18
00884838096745Cardiac WorkstationPhilips Medizin Systeme Böblingen GmbHDPS2026-08-18
06944413844919SE-1202 Series ElectrocardiographEdan Instruments, Inc.DPS2026-07-21
06944413847422SE-1202 Series ElectrocardiographEdan Instruments, Inc.DPS2026-07-21
00850048674028HeartBeam ECG SystemHeartBeam, Inc.DPS2026-07-16
00810209880057CORE 500 Digital Stethoscope - Navy Blue EarpieceEko Health, Inc.DPS2026-06-12
00810209880064CORE 500 Digital Stethoscope - Military Green EarpieceEko Health, Inc.DPS2026-06-12
00810209880071CORE 500 Digital Stethoscope - Navy Blue BundleEko Health, Inc.DPS2026-06-12
00810209880088CORE 500 Digital Stethoscope - Military Green BundleEko Health, Inc.DPS2026-06-12
00732094354959Welch Allyn, Inc.WELCH ALLYN, INC.DPS2026-06-09
00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.DPS2026-06-03
00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.DPS2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DPS2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DPS2026-06-03
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27