Lutech - Multi-parameter patient monitor. 780-N-pM-P - LUTECH INDUSTRIES INC

Duns Number:078698036

Device Description: Multi-parameter patient monitor. 780-N-pM-P

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More Product Details

Catalog Number

-

Brand Name

Lutech

Version/Model Number

Datalys 780

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K150691

Product Code Details

Product Code

DPS

Product Code Name

Electrocardiograph

Device Record Status

Public Device Record Key

b4661acb-554c-4fc9-a6f0-acea9942f071

Public Version Date

November 10, 2021

Public Version Number

5

DI Record Publish Date

September 12, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LUTECH INDUSTRIES INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 113