The following data is part of a premarket notification filed by Sensydia, Inc. with the FDA for Integrated Cardiorespiratory System.
| Device ID | K173156 |
| 510k Number | K173156 |
| Device Name: | Integrated CardioRespiratory System |
| Classification | Electrocardiograph, Ambulatory (without Analysis) |
| Applicant | Sensydia, Inc. 907 Westwood Boulevard, Suite 358 Los Angeles, CA 90024 |
| Contact | Thomas Bruggere |
| Correspondent | Anna Libman Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, CA 95110 |
| Product Code | MWJ |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2018-06-08 |
| Summary: | summary |