510(k) K102120

NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202 by Hsiner Co., Ltd. — Product Code CBK

K102120 is an FDA 510(k) premarket notification submitted by Hsiner Co., Ltd. for the device "NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202". The FDA issued a decision of Substantially Equivalent on August 12, 2011. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Hsiner Co., Ltd. has at least 6 other 510(k) clearances on record.