The SpiroScout SP 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 SP 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. Spiroscout SP is technically identical to Spiroscout and is intended exclusively for use with Schiller’s AT 102
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 SP | 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 |
| Premarket notification | Exempt |
| Record published | 2021-11-30 |
| Record revised | 2022-03-08 (version 2) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 60 to 105 KiloPascal; Storage environment humidity 10 to 95 % RH; Storage 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.