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FDA 510(k)

ENVAN HEART RATE MONITOR

K-Number: K030656 · 2003-04-08

ApplicantEnvan, LLC
Decision Date2003-04-08
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ENVAN HEART RATE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Envan, LLC. It received FDA 510(k) clearance on 2003-04-08 under 510(k) number K030656. 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 ENVAN HEART RATE MONITOR?

ENVAN HEART RATE MONITOR is a medical device that received FDA 510(k) clearance on 2003-04-08. The listed applicant is Envan, LLC. The 510(k) number is K030656.

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

ENVAN HEART RATE MONITOR received FDA 510(k) clearance on 2003-04-08, under 510(k) number K030656.

Who is the listed applicant for ENVAN HEART RATE MONITOR?

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

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

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

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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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