The following data is part of a premarket notification filed by Convexity Scientific Llc with the FDA for Airworks Nebulizer Pe1200m.
| Device ID | K162041 |
| 510k Number | K162041 |
| Device Name: | Airworks Nebulizer Pe1200m |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | Convexity Scientific LLC 36 Church Lane Westport, CT 06880 |
| Contact | Paul Reiferson |
| Correspondent | Susan D. Goldstein-falk mdi Consultants, Inc. 55 Northern Blvd. Great Neck, NY 11021 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-25 |
| Decision Date | 2017-05-02 |
| Summary: | summary |