SpiroLink
This device is intended to monitor a patient’s Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1) at home. The device is designed for adults and children over 5…
This device is intended to monitor a patient’s Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1) at home. The device is designed for adults and children over 5 years of age with caregiver supervision. The device is intended for monitoring respiratory conditions such as asthma.
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.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Shenzhen BI-Rich Medical Devices Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 9 |
| Chongqing Sonmol Technology Co., Ltd. | Chongqing | Chongqing | Contract manufacturer | 9 |
| Onbo Electronic (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Guangzhou Homesun Medical Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 4 |
| Taian Dalu Medical Instrument Co., Ltd. | Taian | Shandong | Contract manufacturer | 2 |
Record
| Listed by | Guangzhou Red Elephant Medical Technology Co., Ltd. |
|---|---|
| FDA product code | BZH |
| Device type | Meter, Peak Flow, Spirometry |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1860 |
| 510(k) | K191239 |
| Record published | 2019-12-19 |
| Record revised | 2021-03-19 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mini Wright | Clement Clarke Intl., Ltd. | 12 |
| Personal Best | Respironics Respiratory Drug Delivery (Uk), Ltd. | 10 |
| In-Check | Clement Clarke Intl., Ltd. | 8 |
| PFM | Vitalograph Ireland Ltd. | 7 |
| SpiroFlow | Spirometrics, Inc. | 4 |
| Meter, Peak Flow, Spirometry | Salter Labs | 3 |
| Airzone | Clement Clarke Intl., Ltd. | 3 |
| AincA® | Anesthesia Associates, Inc. | 3 |
| Meter, Peak Flow, Spirometry | Galemed Corp. | 3 |
| Curaplex | TRI-Anim Health Services, Inc. | 3 |
| Asthma Check | Respironics Respiratory Drug Delivery (Uk), Ltd. | 3 |
| Vyaire | Jaeger Medical GmbH | 2 |
Showing 12 of 53. All products under Meter, Peak Flow, Spirometry
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.