FDA.reportPublic FDA data

Lutech

Primary DI
B299780N0
Brand
Lutech
Company
LUTECH INDUSTRIES INC
Model
Datalys 780
Device description
Multi-parameter patient monitor. 780-N
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DPSElectrocardiograph
DQAOximeter
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
FLLThermometer, Electronic, Clinical
MWIMonitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2
DQAOximeterCardiovascular2
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2
FLLContinuous Measurement ThermometerGeneral Hospital2
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150691000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150691000Datalys Multi-Parameter Patient MonitorLutech Industries, Inc.2015-05-15MWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B299780N0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Transportable physiologic monitoring systemAn assembly of battery-powered devices designed for continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of a patient in transit [e.g., during transport to, between, or within a hospital(s)]. It typically includes a recorder, amplifier, display monitor, and patient leads/attachments; it may also be used by the bedside where it is normally connected to the mains electricity.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078698036
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B299750L0LutechDatalys 7502016-09-12
B299750LC0LutechDatalys 7502016-09-12
B299750LCP0LutechDatalys 7502016-09-12
B299750LI0LutechDatalys 7502016-09-12
B299750LIC0LutechDatalys 7502016-09-12
B299750LICP0LutechDatalys 7502016-09-12
B299750LIP0LutechDatalys 7502016-09-12
B299750LP0LutechDatalys 7502016-09-12
B299750M0LutechDatalys 7502016-09-12
B299750MC0LutechDatalys 7502016-09-12
B299750MCP0LutechDatalys 7502016-09-12
B299750MI0LutechDatalys 7502016-09-12
B299750MIC0LutechDatalys 7502016-09-12
B299750MICP0LutechDatalys 7502016-09-12
B299750MIP0LutechDatalys 7502016-09-12
B299750MP0LutechDatalys 7502016-09-12
B299750N0LutechDatalys 7502016-09-12
B299750NC0LutechDatalys 7502016-09-12
B299750NCP0LutechDatalys 7502016-09-12
B299750NI0LutechDatalys 7502016-09-12

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