Healix Assistant
Ask me anything about our products
Quick questions
Powered by Healix AI · Talk to a human

Biotronik, Inc.
Free shipping on orders over $99 · 30-day returns
ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA 3000 BATTERY (TYPE 2); NK-11 POWER SUPP. is an FDA 510(k)-cleared medical device (K022360) manufactured by Biotronik, 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 January 26, 2003. Regulation: 8.