
Bedside Clinical Systems, Inc.
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BEDSIDE PAEDIATRIC EARLY WARNING SYSTEM (BEDSIDEPEWS) is an FDA 510(k)-cleared medical device (K124038) manufactured by Bedside Clinical Systems, 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 June 20, 2013. Regulation: 8.