The following data is part of a premarket notification filed by Dictum Health, Inc with the FDA for Dictum Health.
| Device ID | K152645 |
| 510k Number | K152645 |
| Device Name: | Dictum Health |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | DICTUM HEALTH, INC 255 3RD AVENUE, SUITE 102 Oakland, CA 94607 |
| Contact | Paul Landesman |
| Correspondent | Daniel Kamm KAMM & ASSOCIATES 8870 RAVELLO CT Naples, FL 34114 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-16 |
| Decision Date | 2016-02-09 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DICTUM HEALTH 86503440 4871916 Live/Registered |
Dictum Health, Inc. 2015-01-14 |