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

FDA 510(k)

SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION

K-Number: K131044 · 2013-09-04

ApplicantDiacoustic Medical Devices (Pty) , Ltd.
Decision Date2013-09-04
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION 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 2013-09-04 under 510(k) number K131044. 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 SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION?

SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION is a medical device that received FDA 510(k) clearance on 2013-09-04. The listed applicant is Diacoustic Medical Devices (Pty) , Ltd.. The 510(k) number is K131044.

When did SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION receive FDA 510(k) clearance?

SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION received FDA 510(k) clearance on 2013-09-04, under 510(k) number K131044.

Who is the listed applicant for SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION?

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 SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION?

The FDA product code for SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION is DQD.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K110704SENSI

Related Devices (Code: DQD)

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.

K261494Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730)Shanghai Hulu Devices Co., Ltd.K261694CORE 300 Digital StethoscopeEko Health, Inc.K252915AiSteth®Ai Health Highway India Pvt., Ltd.K252089Tyto Stethoscope (G3)Tyto Care , Ltd.K252076Kneevoice Cartilage Evaluation System (750-3600-001)Kneevoice, Inc.K252284eMurmur Heart AICsd Labs

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.

↑