SpiroSphere
SpiroSphere is described as a compact spirometry device. The filing says its sensor unit is battery-powered, while the main unit can run on battery or external power. The device filing…
SpiroSphere is described as a compact spirometry device. The filing says its sensor unit is battery-powered, while the main unit can run on battery or external power.
The device filing identifies SpiroSphere as a predicted pulmonary-function value calculator and gives a description of its sensor and main units.
Listed Item
Diagnostic spirometer for measurement and data collection of lung function parameters with option ECG
Device Layout
The summary says the measured data are saved on the device and can be read later. It can also be printed or transferred by USB, Wi-Fi, 3G, or Ethernet.
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Homesun Medical Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 4 |
Record
| Listed by | eResearchTechnology GmbH, Germany |
|---|---|
| FDA product code | BTY |
| Device type | Calculator, Predicted Values, Pulmonary Function |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1890 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K173937 |
| Record published | 2021-02-18 |
| Record revised | 2024-03-19 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SpiroSphere | In distribution | |
| SpiroSphere ECG | In distribution | |
| SpiroSphere Standard ECG | In distribution | |
| SpiroSphere Standard | In distribution | |
| SpiroSphere Main Unit | In distribution | |
| SpiroSphere CT | In distribution | |
| SpiroSphere Standard | In distribution | |
| SpiroSphere Main Unit | In distribution | |
| SpiroSphere Main Unit | In distribution | |
| SpiroSphere CT | In distribution | |
| SpiroSphere CT | In distribution | |
| SpiroSphere | In distribution | |
| SpiroSphere ECG CT | In distribution | |
| SpiroSphere Sensor | In distribution | |
| SpiroSphere Main Unit | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vmax | Carefusion | 59 |
| Vmax | Vyaire Medical, Inc. | 27 |
| Jaeger | Jaeger Medical GmbH | 16 |
| Vyaire | Jaeger Medical GmbH | 8 |
| Cosmed | C O S M E D SRL | 8 |
| MasterScope | eResearchTechnology GmbH | 7 |
| Shape-HF | Shape Medical Systems, Inc | 3 |
| Avea | Vyaire Medical, Inc. | 3 |
| Pneumotach | eResearchTechnology GmbH | 2 |
| ERT PT | eResearchTechnology GmbH | 2 |
| Shape | Shape Medical Systems, Inc | 2 |
| MasterScreen | Jaeger Medical GmbH | 2 |
Showing 12 of 28. All products under Calculator, Predicted Values, Pulmonary Function
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K223629 | 2024-05-28 |
| K202754 | 2021-01-28 |
| K173937 | 2019-02-15 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.