X-PLO2R
Generator, Oxygen, Portable
Belluscura LLC
The following data is part of a premarket notification filed by Belluscura Llc with the FDA for X-plo2r.
Pre-market Notification Details
| Device ID | K203086 |
| 510k Number | K203086 |
| Device Name: | X-PLO2R |
| Classification | Generator, Oxygen, Portable |
| Applicant | Belluscura LLC 5504 Democracy Dr, Suite 200 Plano, TX 75024 |
| Contact | Sarah Clark |
| Correspondent | Kevin Walls Regulatory Insight, Inc 33 Golden Eagle Ln Littleton, CO 80127 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-13 |
| Decision Date | 2021-03-02 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850029991007 | K203086 | 000 |
Trademark Results [X-PLO2R]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 X-PLO2R 97312346 not registered Live/Pending |
Belluscura LLC 2022-03-15 |
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