The following data is part of a premarket notification filed by Instrumentation Industries, Inc. with the FDA for Rtc 26-c Inline Aerosol Adapter.
| Device ID | K162753 |
| 510k Number | K162753 |
| Device Name: | RTC 26-C Inline Aerosol Adapter |
| 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 | 2016-09-30 |
| Decision Date | 2017-02-28 |
| Summary: | summary |