Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Dictum Health

K-Number: K170798 · 2017-07-14

ApplicantDictum Health, Inc.
Decision Date2017-07-14
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Dictum Health is a medical device manufactured by Dictum Health, Inc.. It received FDA 510(k) clearance on 2017-07-14 under approval number K170798. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dictum Health?

Dictum Health is a medical device that received FDA 510(k) clearance on 2017-07-14. It is manufactured by Dictum Health, Inc.. The 510(k) number is K170798.

When was Dictum Health approved by the FDA?

Dictum Health received FDA 510(k) clearance on 2017-07-14, under approval number K170798.

What company makes Dictum Health?

Dictum Health is manufactured by Dictum Health, Inc..

What is the FDA product code for Dictum Health?

The FDA product code for Dictum Health is MWI.

Other Devices by Dictum Health, Inc.

K152645Dictum Health

Related Devices (Code: MWI)

K161909IQvitals ZoneMidmark Corporation K160718Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien K151839AMC Health VitalCaregiving SystemAmc Health K160956LD-Oxi systemLd Technology, LLC K153739MRI Patient Monitor TeslaDUOMipm Mammendorfer Institut Fur Physik Und Medizin K153225Masimo Root Monitoring System and AccessoriesMasimo Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑