The following data is part of a premarket notification filed by Reciprocal Labs Corporation with the FDA for Propeller Sensor For Neohaler.
| Device ID | K180770 |
| 510k Number | K180770 |
| Device Name: | Propeller Sensor For Neohaler |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | Reciprocal Labs Corporation 634 West Main St. Madison, WI 53703 |
| Contact | David Hubanks |
| Correspondent | Taylor Mahan-rudolph Reciprocal Labs Corporation 634 West Main St. 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 | 2018-03-23 |
| Decision Date | 2018-08-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00865528000099 | K180770 | 000 |