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FDA 510(k)

Cardiac Trigger Monitor

K-Number: K202138 · 2021-05-14

ApplicantIvy Biomedical Systems, Inc.
Decision Date2021-05-14
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Cardiac Trigger Monitor is a medical device manufactured by Ivy Biomedical Systems, Inc.. It received FDA 510(k) clearance on 2021-05-14 under approval number K202138. 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 Trigger Monitor is a medical device that received FDA 510(k) clearance on 2021-05-14. It is manufactured by Ivy Biomedical Systems, Inc.. The 510(k) number is K202138.

When was Cardiac Trigger Monitor approved by the FDA?

Cardiac Trigger Monitor received FDA 510(k) clearance on 2021-05-14, under approval number K202138.

What company makes Cardiac Trigger Monitor?

Cardiac Trigger Monitor is manufactured by Ivy Biomedical Systems, Inc..

What is the FDA product code for Cardiac Trigger Monitor?

The FDA product code for Cardiac Trigger Monitor is DRT.

Related Clinical Trials

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Other Devices by Ivy Biomedical Systems, Inc.

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Related Devices (Code: DRT)

K151781Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization MonitorIvy Biomedical Systems, Inc. K170828Cardiac Trigger MonitorIvy Biomedical Systems, Inc. K172586Vios Monitoring System™ Model 2050Vios Medical, Inc. K181165Philips wearable biosensor-G5 SolutionConnected Sensing- A Division of Philips Medical Systems K202464Vital Sign Monitoring Sensor (Model :XK300)Xandar Kardian, Inc. K212143Neteera 130H/131H Vital Sign Monitoring SensorNeteera Technologies , Ltd.

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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