The following data is part of a premarket notification filed by Instrumentation Industries, Inc. with the FDA for Rtc Metered Dose Inhaler Adapters-single Patient Use, Model Rtc 24-v, Rtc Mdi Adapter Kit-single Patient Use, Model Rtc.
| Device ID | K091111 |
| 510k Number | K091111 |
| Device Name: | RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | INSTRUMENTATION INDUSTRIES, INC. 2990 INDUSTRIAL BLVD. Bethel Park, PA 15102 |
| Contact | Doris Walter |
| Correspondent | Doris Walter INSTRUMENTATION INDUSTRIES, INC. 2990 INDUSTRIAL BLVD. Bethel Park, PA 15102 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-17 |
| Decision Date | 2009-12-02 |
| Summary: | summary |