The following data is part of a premarket notification filed by Reciprocal Labs with the FDA for Propeller Sensor Model 2014-r.
| Device ID | K152482 |
| 510k Number | K152482 |
| Device Name: | Propeller Sensor Model 2014-R |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | RECIPROCAL LABS 634 W. MAIN STREET, SUITE 102 Madison, WI 53703 |
| Contact | David Hubanks |
| Correspondent | David Hubanks RECIPROCAL LABS 634 W. MAIN STREET, SUITE 102 Madison, WI 53703 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-31 |
| Decision Date | 2016-03-04 |
| Summary: | summary |