The following data is part of a premarket notification filed by Zynex Medical, Inc. with the FDA for Cardiac Monitor 1500.
| Device ID | K191697 |
| 510k Number | K191697 |
| Device Name: | Cardiac Monitor 1500 |
| Classification | Plethysmograph, Impedance |
| Applicant | Zynex Medical, Inc. 9995 Maroon Circle Englewood, CO 80112 |
| Contact | Thomas Sandgaard |
| Correspondent | Thomas Sandgaard Zynex Medical, Inc. 9995 Maroon Circle Englewood, CO 80112 |
| Product Code | DSB |
| Subsequent Product Code | DQA |
| Subsequent Product Code | FLL |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-25 |
| Decision Date | 2020-02-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852670007151 | K191697 | 000 |