The following data is part of a premarket notification filed by Reciprocal Labs Corporation with the FDA for Propeller Sensor For Symbicort.
| Device ID | K192724 |
| 510k Number | K192724 |
| Device Name: | Propeller Sensor For Symbicort |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | Reciprocal Labs Corporation 1 S. Pinckney St. Suite 610 Madison, WI 53703 |
| Contact | Greg Dunkelberger |
| Correspondent | Greg Dunkelberger Reciprocal Labs Corporation 1 S. Pinckney St. Suite 610 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 | 2019-09-27 |
| Decision Date | 2020-03-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859105006345 | K192724 | 000 |