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)

CADence System

K-Number: K170928 · 2017-08-03

ApplicantAum Cardiovascular, Inc.
Decision Date2017-08-03
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CADence System is the device name listed in this FDA 510(k) record. The listed applicant is Aum Cardiovascular, Inc.. It received FDA 510(k) clearance on 2017-08-03 under 510(k) number K170928. 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 CADence System?

CADence System is a medical device that received FDA 510(k) clearance on 2017-08-03. The listed applicant is Aum Cardiovascular, Inc.. The 510(k) number is K170928.

When did CADence System receive FDA 510(k) clearance?

CADence System received FDA 510(k) clearance on 2017-08-03, under 510(k) number K170928.

Who is the listed applicant for CADence System?

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

What is the FDA product code for CADence System?

The FDA product code for CADence System is DQD.

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.

↑