Aer X
Generator, Oxygen, Portable
3B Medical Inc.
The following data is part of a premarket notification filed by 3b Medical Inc. with the FDA for Aer X.
Pre-market Notification Details
| Device ID | K200496 |
| 510k Number | K200496 |
| Device Name: | Aer X |
| Classification | Generator, Oxygen, Portable |
| Applicant | 3B Medical Inc. 203 Avenue A NW, Suite 300 Winter Haven, FL 33881 |
| Contact | Yasser Estafanous |
| Correspondent | Yasser Estafanous 3B Medical Inc. 203 Avenue A NW, Suite 300 Winter Haven, FL 33881 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-28 |
| Decision Date | 2020-07-24 |
Trademark Results [Aer X]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AER X 88555306 not registered Live/Pending |
3B Medical, Inc. 2019-07-31 |
 AER X 88555137 not registered Live/Pending |
3B Medical, Inc. 2019-07-31 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.