The SpiroScout is a PC based system designed to measure and record FVC and SV Spiro recordings for adult and paediatric patients. Measurements are made with the SpiroScout ultrasound…
The SpiroScout is a PC based system designed to measure and record FVC and SV Spiro recordings for adult and paediatric patients. Measurements are made with the SpiroScout ultrasound sensor. The SpiroScout sensor is supplied with either a disposable single- use ScoutTube, or a disposable single- use PFT Bacterial filter mouthpiece assembly. A ScoutTube or PFT filter is used for every patient to help prevent patient cross contamination. The SpiroScout is available with the following Options. Tidal Breath Analysis for paediatrics Rhinomanometrie Capnovolumetry (evaluation off additional parameters during tidal breathing, see software Ganshorn.LFX) HL7/ network (network connection via software Ganshorn.LFX)
Who Else Makes It
Concentrated in Jiangsu (5), Guangdong (3), Fujian (1). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for SpiroScout | Listed by | Ganshorn Medizin Electronic Gmbh, Germany |
| FDA product code | BZG |
| Device type | Spirometer, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1840 |
| Establishment | Manufacturer |
| 510(k) | K160116 |
| Record published | 2023-07-03 |
| Record revised | 2022-03-08 (version 6) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 60 to 106 KiloPascal; Handling environment humidity 10 to 95 % RH; Handling environment temperature -20 to 50 °C |
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.