The MiniBox is intended to measure lung function in adult and pediatric patients while at rest (including spirometry and lung volumes ). The MiniBox is to be used by either a physician,…
The MiniBox is intended to measure lung function in adult and pediatric patients while at rest (including spirometry and lung volumes ). The MiniBox is to be used by either a physician, respiratory therapist, or technician. A cleared single-use, disposable viral-bacterial filter separates the patient from the internal components of the device.The MiniBox measures all common spirometric measurements as well as relative and absolute lung volumes.
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for MiniBox | Listed by | Pulmone Advanced Medical Devices, Ltd., Israel |
| FDA product code | BZC |
| Device type | Calculator, Pulmonary Function Data |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1880 |
| Establishment | Manufacturer |
| 510(k) | K141793 |
| Record published | 2016-09-24 |
| Record revised | 2022-03-08 (version 5) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
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.