The following data is part of a premarket notification filed by Xandar Kardian Inc. with the FDA for Vital Sign Monitoring Sensor (model :xk300).
| Device ID | K202464 |
| 510k Number | K202464 |
| Device Name: | Vital Sign Monitoring Sensor (Model :XK300) |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | Xandar Kardian Inc. #309, Seongsuil-Ro 10-Gil Seongdong-gu Seoul, KR 04793 |
| Contact | Glen (jeong Woo) Choi |
| Correspondent | Brennan Sullivan Alira Health 1 Grant Street Suite 400 Framingham, MA 01702 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-27 |
| Decision Date | 2021-04-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809988780001 | K202464 | 000 |