510(k) K101857

RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V by Instrumentation Industries, Inc. — Product Code CAF

K101857 is an FDA 510(k) premarket notification submitted by Instrumentation Industries, Inc. for the device "RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V". The FDA issued a decision of Substantially Equivalent on July 22, 2010. 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2010
Date Received
July 2, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type