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Data / Medical devices / United States / Dictum Health, Inc.

Dictum Health, Inc.: FDA-registered device maker in Malibu, CA, United States, 2 510(k) clearances

Dictum Health, Inc. is registered with the FDA (registration 3011359729) in Malibu, CA, United States. It lists 11 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 14, 2017. Registered through 2026. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Dictum Health, Inc.
FDA registration number
3011359729
Address
32860 Pacific Coast Highway, Malibu, CA, United States, 90265
Owner or operator
Dictum Health (10051189)
Roles
Complaint file establishment, Specification developer
First device listed
February 19, 2016
Registered through
2026
Brand names listed
IDM100, eVER-HOME Tablet, eVER-HOME, SpO2 Sensor, Blood Pressure Monitor, Ear Thermometer, eVER-HOME, SpO2 Sensor, Blood Pressure Monitor, Ear Thermometer, Scale, eVERHome

Devices it lists

DeviceProduct codeClassRoleSource
AudiometerEWO2Complaint file establishment, Specification developeraccessdata.fda.gov
Blood Pressure CuffDXQ2Complaint file establishment, Specification developeraccessdata.fda.gov
Continuous Measurement ThermometerFLL2Complaint file establishment, Specification developeraccessdata.fda.gov
ElectrocardiographDPS2Complaint file establishment, Specification developeraccessdata.fda.gov
Electrode, ElectrocardiographDRX2Complaint file establishment, Specification developeraccessdata.fda.gov
Monitor, Bed PatientKMI1Complaint file establishment, Specification developeraccessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)MWI2Complaint file establishment, Specification developeraccessdata.fda.gov
OximeterDQA2Complaint file establishment, Specification developeraccessdata.fda.gov
Spirometer, DiagnosticBZG2Complaint file establishment, Specification developeraccessdata.fda.gov
Stethoscope, ElectronicDQD2Complaint file establishment, Specification developeraccessdata.fda.gov
System, Measurement, Blood-Pressure, Non-InvasiveDXN2Complaint file establishment, Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
July 14, 2017K170798Dictum HealthMWISubstantially EquivalentDictum Health, Inc.accessdata.fda.gov
February 9, 2016K152645Dictum HealthMWISubstantially EquivalentDictum Health, Inc.accessdata.fda.gov

Compare with other makers

Updated July 14, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.