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FDA 510(k)

PRO-SPORT HEART RATE MONITOR

K-Number: K943242 · 1995-03-10

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

Device Summary

PRO-SPORT 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 K943242. 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 PRO-SPORT HEART RATE MONITOR?

PRO-SPORT 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 K943242.

When did PRO-SPORT HEART RATE MONITOR receive FDA 510(k) clearance?

PRO-SPORT HEART RATE MONITOR received FDA 510(k) clearance on 1995-03-10, under 510(k) number K943242.

Who is the listed applicant for PRO-SPORT 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 PRO-SPORT HEART RATE MONITOR?

The FDA product code for PRO-SPORT 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.

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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.

K943243PULSE 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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