The following data is part of a premarket notification filed by Reciprocal Labs Corporation with the FDA for Asthmapolis System.
| Device ID | K121609 |
| 510k Number | K121609 |
| Device Name: | ASTHMAPOLIS SYSTEM |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | RECIPROCAL LABS CORPORATION 612 W. MAIN STREET STE. 201 Madison, WI 53703 |
| Contact | Inger L Couture |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-06-01 |
| Decision Date | 2012-07-02 |
| Summary: | summary |