510(k) K981249

METERED DOSE INHALER-REUSABLE MODEL NUMBER RTC 21-A, METERED DOSE INHALER-DISPOSABLE MODEL NUBER RTC 21-D by Instrumentation Industries, Inc. — Product Code CAF

K981249 is an FDA 510(k) premarket notification submitted by Instrumentation Industries, Inc. for the device "METERED DOSE INHALER-REUSABLE MODEL NUMBER RTC 21-A, METERED DOSE INHALER-DISPOSABLE MODEL NUBER RTC 21-D". The FDA issued a decision of Substantially Equivalent on November 23, 1998. 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.