Prucka Engineering, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Prucka Engineering, Inc. makes
Prucka Engineering, Inc. manufactures systems and components for electrophysiology (EP) labs, including catheterization lab systems, intracardiac mapping devices, and specialized electrode arrays for plaque assessment. Their portfolio includes amplifier modules for signal amplification and comprehensive EP lab systems designed for diagnostic and procedural support in cardiac electrophysiology.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) clearance registry. Products are intended for use in cardiac electrophysiology procedures and are based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Cardiocath Catheterization Lab System Ref K960321
Regimes: 510(k) Registry: 510(k)Pe Intercardiac Mapping System (Icms) Ref K895916
Regimes: 510(k) Registry: 510(k)Pei Plaque Electrode Array Ref K904747
Regimes: 510(k) Registry: 510(k)Cardiolab Amplifier Module (Cam) Ref K910307
Regimes: 510(k) Registry: 510(k)Pe Electrophysiology Lab System (Peep) Ref K902716
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Prucka Engineering, Inc. have in the registry?
The registry currently lists 6 devices for Prucka Engineering, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Prucka Engineering, Inc.'s devices?
Among its 6 most recently registered devices, Prucka Engineering, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Prucka Engineering, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Prucka Engineering, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Prucka Engineering, Inc. in the registry?
The most recently registered devices listed for Prucka Engineering, Inc. include PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM, VERSION 4.2, CARDIOCATH CATHETERIZATION LAB SYSTEM, PE INTERCARDIAC MAPPING SYSTEM (ICMS) and PEI PLAQUE ELECTRODE ARRAY.