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 |