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FDA 510(k)

SENSI

K-Number: K110704 · 2011-06-24

ApplicantDiacoustic Medical Devices (Pty) , Ltd.
Decision Date2011-06-24
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SENSI is the device name listed in this FDA 510(k) record. The listed applicant is Diacoustic Medical Devices (Pty) , Ltd.. It received FDA 510(k) clearance on 2011-06-24 under 510(k) number K110704. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENSI?

SENSI is a medical device that received FDA 510(k) clearance on 2011-06-24. The listed applicant is Diacoustic Medical Devices (Pty) , Ltd.. The 510(k) number is K110704.

When did SENSI receive FDA 510(k) clearance?

SENSI received FDA 510(k) clearance on 2011-06-24, under 510(k) number K110704.

Who is the listed applicant for SENSI?

The FDA 510(k) record lists Diacoustic Medical Devices (Pty) , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SENSI?

The FDA product code for SENSI is DQD.

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Related PubMed Literature

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.

PMID: 42686814Sensitivity of 510(k) medical device filings to government shutdowns: a brief communication.npj health systems ()

Other records listing Diacoustic Medical Devices (Pty) , Ltd. 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.

K131044SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION

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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.

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