Oxxiom
Oximeter
True Wearables, Inc.
The following data is part of a premarket notification filed by True Wearables, Inc. with the FDA for Oxxiom.
Pre-market Notification Details
| Device ID | K200537 |
| 510k Number | K200537 |
| Device Name: | Oxxiom |
| Classification | Oximeter |
| Applicant | True Wearables, Inc. 29826 Avenida De Las Banderas, Suite 300 Rancho Santa Margarita, CA 92688 |
| Contact | Marcelo Lamego |
| Correspondent | Amy Fowler Gardner Law, PLLC 423 Main Street Stillwater, MN 55082 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-03 |
| Decision Date | 2020-07-03 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B944TWPD1DA0320150 | K200537 | 000 |
Trademark Results [Oxxiom]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OXXIOM 86856009 5612250 Live/Registered |
TRUE WEARABLES, INC. 2015-12-21 |
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