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FDA 510(k)

ECARD AND CCARD

K-Number: K081471 · 2008-06-24

ApplicantiRhythm Technologies, Inc.
Decision Date2008-06-24
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECARD AND CCARD is the device name listed in this FDA 510(k) record. The listed applicant is iRhythm Technologies, Inc.. It received FDA 510(k) clearance on 2008-06-24 under 510(k) number K081471. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECARD AND CCARD?

ECARD AND CCARD is a medical device that received FDA 510(k) clearance on 2008-06-24. The listed applicant is iRhythm Technologies, Inc.. The 510(k) number is K081471.

When did ECARD AND CCARD receive FDA 510(k) clearance?

ECARD AND CCARD received FDA 510(k) clearance on 2008-06-24, under 510(k) number K081471.

Who is the listed applicant for ECARD AND CCARD?

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

What is the FDA product code for ECARD AND CCARD?

The FDA product code for ECARD AND CCARD is DXH. This falls under the Hematology category.

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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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