510(k) K092129

INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330 by Intersurgical, Inc. — Product Code BZE

K092129 is an FDA 510(k) premarket notification submitted by Intersurgical, Inc. for the device "INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330". The FDA issued a decision of Substantially Equivalent on May 18, 2010. The device falls under product code BZE (Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer), a Class II device regulated under 21 CFR 868.5270. Intersurgical, Inc. has at least 10 other 510(k) clearances on record.