Life Sensing Instruments, Inc. - Windows 7 Tower which is part of a multi-patient - LIFE SENSING INSTRUMENTS, INC.

Duns Number:080677893

Device Description: Windows 7 Tower which is part of a multi-patient physiologic monitoring system

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More Product Details

Catalog Number

-

Brand Name

Life Sensing Instruments, Inc.

Version/Model Number

HTS820 Windows 7

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K896967

Product Code Details

Product Code

DSI

Product Code Name

Detector And Alarm, Arrhythmia

Device Record Status

Public Device Record Key

4d306b49-72ac-4687-81fc-464cc15fabe9

Public Version Date

February 06, 2020

Public Version Number

4

DI Record Publish Date

September 12, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LIFE SENSING INSTRUMENTS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 12