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FDA 510(k)

Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor

K-Number: K151781 · 2016-05-27

ApplicantIvy Biomedical Systems, Inc.
Decision Date2016-05-27
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Ivy Biomedical Systems, Inc.. It received FDA 510(k) clearance on 2016-05-27 under 510(k) number K151781. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor?

Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor is a medical device that received FDA 510(k) clearance on 2016-05-27. The listed applicant is Ivy Biomedical Systems, Inc.. The 510(k) number is K151781.

When did Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor receive FDA 510(k) clearance?

Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor received FDA 510(k) clearance on 2016-05-27, under 510(k) number K151781.

Who is the listed applicant for Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor?

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

What is the FDA product code for Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor?

The FDA product code for Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor is DRT.

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Related Devices (Code: DRT)

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.

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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.

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