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.
Device ID | K101857 |
510k Number | K101857 |
Device Name: | RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V |
Classification | Nebulizer (direct Patient Interface) |
Applicant | INSTRUMENTATION INDUSTRIES, INC. 2990 INDUSTRIAL BLVD. Bethel Park, PA 15102 |
Contact | Doris F Walter |
Correspondent | Doris F Walter INSTRUMENTATION INDUSTRIES, INC. 2990 INDUSTRIAL BLVD. Bethel Park, PA 15102 |
Product Code | CAF |
CFR Regulation Number | 868.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-07-02 |
Decision Date | 2010-07-22 |
Summary: | summary |