Empire Plastics Manufacturer
Country not established
- Devices
- 4
What Empire Plastics Manufacturer makes
Empire Plastics Manufacturer produces respiratory diagnostic and exercise devices, including a spirometer for lung function monitoring, an alarm system for use with spirometers, and a counter unit for tracking measurements. Their portfolio also includes a lung function amplifier and an exercise device designed for respiratory training.
The company’s devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. These products are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Alarm Used W/Monitoring Spirometer Ref K792573
Regimes: 510(k) Registry: 510(k)Empire Spirometer Ref K792572
Regimes: 510(k) Registry: 510(k)Counter Unit Ref K792571
Regimes: 510(k) Registry: 510(k)Lung Function Amplifier Exerciser Ref K790744
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Empire Plastics Manufacturer have in the registry?
The registry currently lists 4 devices for Empire Plastics Manufacturer. Devices recorded under merged duplicate company entries are counted once.
Which registries list Empire Plastics Manufacturer's devices?
Among its 4 most recently registered devices, Empire Plastics Manufacturer has devices listed in FDA 510(k) (4 devices).
What risk classes do Empire Plastics Manufacturer's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Empire Plastics Manufacturer's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Empire Plastics Manufacturer in the registry?
The most recently registered devices listed for Empire Plastics Manufacturer include ALARM USED W/MONITORING SPIROMETER, EMPIRE SPIROMETER, COUNTER UNIT and LUNG FUNCTION AMPLIFIER EXERCISER.