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FDA 510(k)

Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth

K-Number: K182196 · 2018-09-11

Decision Date2018-09-11
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth is the device name listed in this FDA 510(k) record. The listed applicant is Imediplus, Inc.. It received FDA 510(k) clearance on 2018-09-11 under 510(k) number K182196. 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 Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth?

Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth is a medical device that received FDA 510(k) clearance on 2018-09-11. The listed applicant is Imediplus, Inc.. The 510(k) number is K182196.

When did Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth receive FDA 510(k) clearance?

Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth received FDA 510(k) clearance on 2018-09-11, under 510(k) number K182196.

Who is the listed applicant for Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth?

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

What is the FDA product code for Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth?

The FDA product code for Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth is DQD.

Other records listing Imediplus, 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.

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.

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.