NxGen Peak Flow Meter is intended to measure Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1) in home healthcare environment. The device is designed for children…
NxGen Peak Flow Meter is intended to measure Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1) in home healthcare environment. The device is designed for children greater than five years of age, adolescent and adult subjects.
Who Else Makes It
Concentrated in Guangdong (4), Chongqing (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for NxGen Peak Flow Meter | Listed by | Safey Medical Devices Pvt, Ltd., India |
| FDA product code | BZH |
| Device type | Meter, Peak Flow, Spirometry |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1860 |
| 510(k) | K200832 |
| Record published | 2025-01-27 |
| Record revised | 2025-03-31 (version 2) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Handling environment temperature -10 to 70 °C; Handling environment atmospheric pressure 75 to 100 KiloPascal; Handling environment humidity 10 to 90 % RH |
| Sizes | Weight 300 g |
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.