510(k) K954750

PEDIATRIC WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE by Unomedical Sdn Bhd — Product Code BTR

K954750 is an FDA 510(k) premarket notification submitted by Unomedical Sdn Bhd for the device "PEDIATRIC WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE". The FDA issued a decision of Substantially Equivalent on December 8, 1995. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. Unomedical Sdn Bhd has at least 10 other 510(k) clearances on record.