RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V

Nebulizer (direct Patient Interface)

INSTRUMENTATION INDUSTRIES, INC.

The following data is part of a premarket notification filed by Instrumentation Industries, Inc. with the FDA for Rtc-24 Vp Metered Dose Inhaler Adapter, Model Rtc 24-v.

Pre-market Notification Details

Device IDK101857
510k NumberK101857
Device Name:RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V
ClassificationNebulizer (direct Patient Interface)
Applicant INSTRUMENTATION INDUSTRIES, INC. 2990 INDUSTRIAL BLVD. Bethel Park,  PA  15102
ContactDoris F Walter
CorrespondentDoris F Walter
INSTRUMENTATION INDUSTRIES, INC. 2990 INDUSTRIAL BLVD. Bethel Park,  PA  15102
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-07-02
Decision Date2010-07-22
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.