PE ELECTROPHYSIOLOGY LAB SYSTEM (PEEP)

PE ELECTROPHYSIOLOGY LAB SYSTEM (PEEP) is an FDA 510(k)-cleared medical device (K902716) manufactured by Prucka Engineering, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 3, 1990. Regulation: 8.