Biotrine Corp.
United StatesFDA applicant, unverified
- Devices
- 6
What Biotrine Corp. makes
Biotrine Corp. manufactures respiratory diagnostic and therapeutic devices, including peak flow meters (e.g., PEAK FLOW MONITOR, ASTECH HOME PEAK FLOW METER) for assessing lung function, and nebulizer systems (e.g., MULTIICHALLENGE NEBULIZER SYSTEM) for delivering inhaled medications. Their product line also includes spirometry devices (e.g., MULTISPIRO SA/100) for measuring airflow and lung volume, as well as portable spirometers (e.g., FLO-COR I) for clinical or home use. Additional offerings include a handheld spirometer (B-1000) for basic pulmonary function testing.
The company’s devices are classified under Class II in the US and are listed via the FDA’s 510(k) pathway, indicating they meet regulatory requirements for moderate-risk medical instruments. Their products are intended for use in clinical, home, and diagnostic settings. Biotrine Corp. is based in the United States.
Catalogue
Peak Flow Monitor Ref K813414
Regimes: 510(k) Registry: 510(k)Flo-Cor I Ref K812825
Regimes: 510(k) Registry: 510(k)Multispiro SA/100 Ref K863134
Regimes: 510(k) Registry: 510(k)B-1000 Ref K844226
Regimes: 510(k) Registry: 510(k)Astech Home Peak Flow Meter Ref K915060
Regimes: 510(k) Registry: 510(k)Multiichallenge Nebulizer System Ref K883704
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biotrine Corp. have in the registry?
The registry currently lists 6 devices for Biotrine Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biotrine Corp.'s devices?
Among its 6 most recently registered devices, Biotrine Corp. has devices listed in FDA 510(k) (6 devices).
What risk classes do Biotrine Corp.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Biotrine Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biotrine Corp. in the registry?
The most recently registered devices listed for Biotrine Corp. include PEAK FLOW MONITOR, FLO-COR I, MULTISPIRO SA/100 and B-1000.