GoSpiro - Device Description:The GoSpiro® is intended to be - MONITORED THERAPEUTICS, INC.

Duns Number:079316129

Device Description: Device Description:The GoSpiro® is intended to be used by adults and children over 5 years Device Description:The GoSpiro® is intended to be used by adults and children over 5 years old in physician’s offices, clinicsand home settings to conduct basic lung function and spirometry testing. It is a single-patient, use device.The GoSpiro spirometer transmits real-time lung function data to computers, tablets or smartphones over aBluetooth connection for tele-healthcare applications. The GoSpiro performs full flow-volume loopsincluding inspiratory and expiratory data. The internal program performs all of the calculations formeasurements to meet American Thoracic Society and European Respiratory Society requirements. It hasbuilt-in quality control measurements and transmits indices of measurement quality including time to peakflow, back-extrapolated volume, total expiratory time, and end-expiratory flow detection.It is used with the GoSpiro App display and communications software on a smartphone or tablet.The GoSpiro is powered by an internal rechargeable Lithium battery and is charged via its USB chargingstation connected to a USB power source. The device complies with ES 60601-1, IEC 60601-1-2, and IEC60601-1-11.The fundamental technology to measure flow is a vertical turbine volume sensor. The turbine transducermeasures expired air directly at B.T.P.S. (body temperature and pressure with saturated water vapor) thusavoiding the requirement for temperature correction on exhalation. An electronic temperature sensor on thedevice PCB measures atmospheric temperature, thus enabling correction of inspired volumes and flows. Thistransducer is insensitive to the effects of condensation and temperature and avoids the need for individualcalibration prior to performing a test.Indications for Use:The GoSpiro® is intended to be used by adults and children over 5 years old in physician’s offices, clinicsand home settings to conduct basic lung function and spirometry testing. It is a single-patient use device.

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More Product Details

Catalog Number

45-90058

Brand Name

GoSpiro

Version/Model Number

45-90058

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K163249

Product Code Details

Product Code

BZG

Product Code Name

Spirometer, Diagnostic

Device Record Status

Public Device Record Key

4fa70003-2679-4d3b-9526-b37fb6895237

Public Version Date

March 08, 2022

Public Version Number

3

DI Record Publish Date

February 02, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

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