The following data is part of a premarket notification filed by Instrumentation Industries, Inc. with the FDA for Metered Dose Inhaler-reusable Model Number Rtc 21-a, Metered Dose Inhaler-disposable Model Nuber Rtc 21-d.
| Device ID | K981249 |
| 510k Number | K981249 |
| Device Name: | METERED DOSE INHALER-REUSABLE MODEL NUMBER RTC 21-A, METERED DOSE INHALER-DISPOSABLE MODEL NUBER RTC 21-D |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | INSTRUMENTATION INDUSTRIES, INC. 2990 INDUSTRIAL BLVD. Bethel Park, PA 15102 |
| Contact | Lori Zuravleff |
| Correspondent | Lori Zuravleff 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 | 1998-04-06 |
| Decision Date | 1998-11-23 |