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FDA 510(k)

PULSE HEART RATE MONITOR

K-Number: K943243 · 1995-03-10

ApplicantSensor Dynamics, Inc.
Decision Date1995-03-10
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PULSE HEART RATE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Sensor Dynamics, Inc.. It received FDA 510(k) clearance on 1995-03-10 under 510(k) number K943243. 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 PULSE HEART RATE MONITOR?

PULSE HEART RATE MONITOR is a medical device that received FDA 510(k) clearance on 1995-03-10. The listed applicant is Sensor Dynamics, Inc.. The 510(k) number is K943243.

When did PULSE HEART RATE MONITOR receive FDA 510(k) clearance?

PULSE HEART RATE MONITOR received FDA 510(k) clearance on 1995-03-10, under 510(k) number K943243.

Who is the listed applicant for PULSE HEART RATE MONITOR?

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

What is the FDA product code for PULSE HEART RATE MONITOR?

The FDA product code for PULSE HEART RATE MONITOR is DRT.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sensor Dynamics, 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.

K943242PRO-SPORT HEART RATE MONITOR

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.

K254058DistaSense(TM) (v1)Life Detection TechnologiesK261286The 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.

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.

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