PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601

PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601 is an FDA 510(k)-cleared medical device (K032038) manufactured by Quinton, 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 4, 2003. Regulation: 8.