LD-Oxy - To spot check or monitor Oxygen saturation of - LD TECHNOLOGY, LLC

Duns Number:079443785

Device Description: To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate. To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate. To analyze the pulse waveform (Photoelectrical Plethysmography or PP) provided by the oximeter. It only provides mathematical analyses of the input of the SpO2 measurement. To analyze the basic rhythms of the NN or RR intervals in heart rate, both in the time domain and in the frequency domain (short time 5 minutes). It only provides mathematical analysis of the input of the heart rate variability. The mathematical analysis of Photoelectrical Plethysmography and HRV ARE NOT intended use for diagnosis. The software provides a visual alarm for the values of the heart rate and/or SpO2 percent out of the normal range and for the bad quality signal transmission. The data are stored in PC in the Backup system of the LD-Oxi software. The device is intended use only for adult subjects (> 20 years old) This Oximeter is intended to be used in spot-checking (5 minutes). The device is intended use in licensed practitioner’s office This device is no intended to be used at home, in hospital or out-of-hospital transport The device is not intended use in support life and not for continuously monitoring The system will be use by practitioner.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

LD-Oxy

Version/Model Number

D001

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

K160956

Product Code Details

Product Code

MWI

Product Code Name

Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Device Record Status

Public Device Record Key

23728be5-d86c-4cc4-8ac7-30d3404a503e

Public Version Date

February 18, 2019

Public Version Number

1

DI Record Publish Date

January 16, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LD TECHNOLOGY, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4