The following data is part of a premarket notification filed by Reciprocal Labs Corporation with the FDA for Propeller Sensor Model 2015-e.
| Device ID | K161454 |
| 510k Number | K161454 |
| Device Name: | Propeller Sensor Model 2015-E |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | Reciprocal Labs Corporation 634 W. Main Street, Suite 102 Madison, WI 53703 |
| Contact | Taylor Mahan-rudolph |
| Correspondent | Taylor Mahan-rudolph Reciprocal Labs Corporation 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 | 2016-05-26 |
| Decision Date | 2016-11-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00865528000068 | K161454 | 000 |