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

Biocare Systems, Inc.
Free shipping on orders over $99 · 30-day returns
BIOCARE SYSTEMS PREMIR 818 is an FDA 510(k)-cleared medical device (K042532) manufactured by Biocare Systems, Inc.. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 12, 2004. Regulation: 8.