The following data is part of a premarket notification filed by Eko Devices Inc with the FDA for Eko Analysis Software.
| Device ID | K192004 |
| 510k Number | K192004 |
| Device Name: | Eko Analysis Software |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | Eko Devices Inc 2600 10TH ST,SUITE 260 Berkeley, CA 94710 |
| Contact | Connor Landgraf |
| Correspondent | Yarmela Pavlovic Manatt, Phelps & Phillips, LLP One Embarcadero Center 30th Floor San Francisco, CA 94111 |
| Product Code | MWI |
| Subsequent Product Code | DPS |
| Subsequent Product Code | DQD |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-26 |
| Decision Date | 2020-01-15 |