SINGLEDAY INFUSOR 2 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL, INFUSOR SV 5 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL CY

SINGLEDAY INFUSOR 2 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL, INFUSOR SV 5 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL CY is an FDA 510(k)-cleared medical device (K982102) manufactured by Baxter Healthcare Corp. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 3, 1998. Regulation: 8.