E.A. Fischione Instrument Mfg.
Country not established
- Devices
- 2
What E.A. Fischione Instrument Mfg. makes
E.A. Fischione Instrument Mfg. manufactures angioplasty pressure measurement devices, including the Model 1000 APC for monitoring pressure during angioplasty procedures and the Model 1100 APC for controlling angioplasty pressure in clinical settings.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
Model 1000 Apc-Angioplasty Pressure Ref K841493
Regimes: 510(k) Registry: 510(k)Model 1100 Apc(Angioplasty Pressure Controller) Ref K853136
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does E.A. Fischione Instrument Mfg. have in the registry?
The registry currently lists 2 devices for E.A. Fischione Instrument Mfg.. Devices recorded under merged duplicate company entries are counted once.
Which registries list E.A. Fischione Instrument Mfg.'s devices?
Among its 2 most recently registered devices, E.A. Fischione Instrument Mfg. has devices listed in FDA 510(k) (2 devices).
What risk classes do E.A. Fischione Instrument Mfg.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for E.A. Fischione Instrument Mfg.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from E.A. Fischione Instrument Mfg. in the registry?
The most recently registered devices listed for E.A. Fischione Instrument Mfg. include MODEL 1000 APC-ANGIOPLASTY PRESSURE and MODEL 1100 APC(ANGIOPLASTY PRESSURE CONTROLLER).