
Datascope Corp.
Free shipping on orders over $99 · 30-day returns
PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX is an FDA 510(k)-cleared medical device (K020550) manufactured by Datascope Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 27, 2002. Regulation: 8.