DROWZLE
Ventilatory Effort Recorder
Resonea, Inc.
The following data is part of a premarket notification filed by Resonea, Inc. with the FDA for Drowzle.
Pre-market Notification Details
| Device ID | K173974 |
| 510k Number | K173974 |
| Device Name: | DROWZLE |
| Classification | Ventilatory Effort Recorder |
| Applicant | Resonea, Inc. 11445 E Via Linda Suite 24 Scottsdale, AZ 85259 |
| Contact | Ruchir Sehra |
| Correspondent | Melissa Walker Graematter Inc 1324 Clarkson Clayton Center #332 St Louis, MO 63011 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-29 |
| Decision Date | 2019-07-14 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860004872405 | K173974 | 000 |
| 00864458000452 | K173974 | 000 |
Trademark Results [DROWZLE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DROWZLE 88155044 5802446 Live/Registered |
Resonea, Inc. 2018-10-15 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.