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FDA 510(k)

ALIVECOR HEART MONITOR

K-Number: K130409 · 2013-09-06

ApplicantAliveCor, Inc.
Decision Date2013-09-06
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ALIVECOR HEART MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is AliveCor, Inc.. It received FDA 510(k) clearance on 2013-09-06 under 510(k) number K130409. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALIVECOR HEART MONITOR?

ALIVECOR HEART MONITOR is a medical device that received FDA 510(k) clearance on 2013-09-06. The listed applicant is AliveCor, Inc.. The 510(k) number is K130409.

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

ALIVECOR HEART MONITOR received FDA 510(k) clearance on 2013-09-06, under 510(k) number K130409.

Who is the listed applicant for ALIVECOR HEART MONITOR?

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

What is the FDA product code for ALIVECOR HEART MONITOR?

The FDA product code for ALIVECOR HEART MONITOR is DPS.

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Other records listing AliveCor, Inc. as applicant

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Related Devices (Code: DPS)

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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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