510(k) K091111

RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC by Instrumentation Industries, Inc. — Product Code CAF

K091111 is an FDA 510(k) premarket notification submitted by Instrumentation Industries, Inc. for the device "RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC". The FDA issued a decision of Substantially Equivalent on December 2, 2009. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Instrumentation Industries, Inc. has at least 10 other 510(k) clearances on record.