FDA.reportPublic FDA data

MONITORED THERAPEUTICS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30122505363012250536MONITORED THERAPEUTICS, INC.1Y2026-01-015160 Blazer Parkway Dublin OH US 43017

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00199874112060CliniSphere - A cloud-based software that collects, displays, analyzes, and transmits patient respiratory and physiological data from Bluetooth connected medical devices (spirometry, oximetry, BP, weight, etc.). Provides dashboards, and communication tools for clinicians to support patient management and communicate with patients.614-761-3555support@monitoredrx.com
00860000692809GoSpiro - 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.614-761-3555jim.kamnikar@monitoredrx.com
00860000692823Turbine Assembly, Bagged for GoSpiro Spirometer - 45-90133614-761-3555jim.kamnikar@monitoredrx.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1906131534915910K202837GoSpiroBZG2020-12-04
1906131652976652K183369COR12 ECGDPS2018-12-28
1906131543171089K163249GoSpiroBZG2017-03-24
1906131404338427
1906131688796329
1906131693516472
1906131703762110
1906131709355377
1906131948727694

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
BZG22020-12-04
DPS12018-12-28

PMN#

GoSpiro

2020-12-04

Monitored Therapeutics, Inc.

GoSpiro

2017-03-24

MONITORED THERAPEUTICS, INC.

GUDID#

GoSpiro - 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.

Monitored Therapeutics, Inc.

2019-02-02