The following data is part of a premarket notification filed by Careox, Llc with the FDA for Percent Oxygen Sensors.
| Device ID | K213933 |
| 510k Number | K213933 |
| Device Name: | Percent Oxygen Sensors |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| Applicant | CareOx, LLC 103 Carnegie Center, Suite 300 Princeton, NJ 08540 |
| Contact | Young Kim |
| Correspondent | Paul Dryden ProMedic Consulting, LLC 131 Bay Point Dr NE Saint Petersburg, FL 33704 |
| Product Code | CCL |
| CFR Regulation Number | 868.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-16 |
| Decision Date | 2022-08-19 |