FDA 510(k)

Dictum Health

K-Number: K170798 · 2017-07-14

Decision Date2017-07-14

Product CodeMWI

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Dictum Health is the device name listed in this FDA 510(k) record. The listed applicant is Dictum Health, Inc.. It received FDA 510(k) clearance on 2017-07-14 under 510(k) 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. The listed applicant is Dictum Health, Inc.. The 510(k) number is K170798.

When did Dictum Health receive FDA 510(k) clearance?

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

Who is the listed applicant for Dictum Health?

The FDA 510(k) record lists Dictum Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dictum Health?

The FDA product code for Dictum Health is MWI.

Other records listing Dictum Health, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K152645Dictum Health

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Official Source

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