The following data is part of a premarket notification filed by Reciprocal Labs Corporation with the FDA for Propeller System - Model 2.
| Device ID | K140638 |
| 510k Number | K140638 |
| Device Name: | PROPELLER SYSTEM - MODEL 2 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | RECIPROCAL LABS CORPORATION 634 W Main St Ste 102 Madison, WI 53703 |
| Contact | J. David Sickle |
| 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 | 2014-03-12 |
| Decision Date | 2014-05-02 |
| Summary: | summary |