Prucka Engineering, Inc. - FDA 510(k) Cleared Devices
Recent clearances: PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2, CARDIOCATH CATHETERIZATION LAB SYSTEM
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Prucka Engineering, Inc. Cardiovascular ✕
6 devices
Cleared
Apr 07, 2000
PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2
Cardiovascular
178d
Cleared
Aug 21, 1996
CARDIOCATH CATHETERIZATION LAB SYSTEM
Cardiovascular
212d
Cleared
Oct 09, 1991
PEI PLAQUE ELECTRODE ARRAY
Cardiovascular
355d
Cleared
Apr 12, 1991
CARDIOLAB AMPLIFIER MODULE (CAM)
Cardiovascular
78d
Cleared
Sep 04, 1990
PE ELECTROPHYSIOLOGY LAB SYSTEM (PEEP)
Cardiovascular
76d
Cleared
Dec 13, 1989
PE INTERCARDIAC MAPPING SYSTEM (ICMS)
Cardiovascular
64d