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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 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 2021-05-14 under 510(k) 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. The listed applicant is Ivy Biomedical Systems, Inc.. The 510(k) number is K202138.

When did Cardiac Trigger Monitor receive FDA 510(k) clearance?

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

Who is the listed applicant for Cardiac Trigger 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?

The FDA product code for Cardiac Trigger Monitor is DRT.

Other records listing Ivy Biomedical Systems, Inc. as applicant

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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.

K261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AGK251364Sleepiz One+ (2.5)Sleepiz AGK234003The Circadia C200 SystemCircadia Technologies, Ltd.K232354Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server SoftwareMurata Vios, Inc.

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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