Identity
- Trade Name
- GoSpiro FDA UDI
- Generic Name
- Diagnostic spirometer, professional FDA UDI
- Device Name
- Device Description: The GoSpiro® is intended to be used by adults and children over 5 years old in physician’s offices, clinics and 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 a Bluetooth connection for tele-healthcare applications. The GoSpiro performs full flow-volume loops including inspiratory and expiratory data. The internal program performs all of the calculations for measurements to meet American Thoracic Society and European Respiratory Society requirements. It has built-in quality control measurements and transmits indices of measurement quality including time to peak flow, 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 charging station connected to a USB power source. The device complies with ES 60601-1, IEC 60601-1-2, and IEC 60601-1-11. The fundamental technology to measure flow is a vertical turbine volume sensor. The turbine transducer measures expired air directly at B.T.P.S. (body temperature and pressure with saturated water vapor) thus avoiding the requirement for temperature correction on exhalation. An electronic temperature sensor on the device PCB measures atmospheric temperature, thus enabling correction of inspired volumes and flows. This transducer is insensitive to the effects of condensation and temperature and avoids the need for individual calibration 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, clinics and home settings to conduct basic lung function and spirometry testing. It is a single-patient use device. FDA UDI
- Model / Reference
- 45-90058 FDA UDI
- Description
- Device Description: The GoSpiro® is intended to be used by adults and children over 5 years old in physician’s offices, clinics and 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 a Bluetooth connection for tele-healthcare applications. The GoSpiro performs full flow-volume loops including inspiratory and expiratory data. The internal program performs all of the calculations for measurements to meet American Thoracic Society and European Respiratory Society requirements. It has built-in quality control measurements and transmits indices of measurement quality including time to peak flow, 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 charging station connected to a USB power source. The device complies with ES 60601-1, IEC 60601-1-2, and IEC 60601-1-11. The fundamental technology to measure flow is a vertical turbine volume sensor. The turbine transducer measures expired air directly at B.T.P.S. (body temperature and pressure with saturated water vapor) thus avoiding the requirement for temperature correction on exhalation. An electronic temperature sensor on the device PCB measures atmospheric temperature, thus enabling correction of inspired volumes and flows. This transducer is insensitive to the effects of condensation and temperature and avoids the need for individual calibration 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, clinics and home settings to conduct basic lung function and spirometry testing. It is a single-patient use device. FDA UDI
Identifiers
- Catalog Number
- 45-90058 FDA UDI
- Primary DI / UDI-DI
- 00860000692809 FDA UDI
- 510(k) Number
- K163249 FDA UDI
- FDA Product Code
- BZG FDA UDI
- GMDN Term
- Diagnostic spirometer, professional FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1840 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Diagnostic spirometer, professional
GoSpiro by Monitored Therapeutics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K163249 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Monitored Therapeutics, Inc.
Sources (1)
- FDA UDI 4fa70003-2679-4d3b-9526-b37fb6895237 37 fields · synced May 30, 2026