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

Datex-Ohmeda, Inc.
Free shipping on orders over $99 · 30-day returns
POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR is an FDA 510(k)-cleared medical device (K031124) manufactured by Datex-Ohmeda, 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 December 3, 2003. Regulation: 8.