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FDA 510(k)

HEART 2005

K-Number: K000775 · 2000-05-17

ApplicantAerotel Medical Systems (1998) , Ltd.
Decision Date2000-05-17
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEART 2005 is the device name listed in this FDA 510(k) record. The listed applicant is Aerotel Medical Systems (1998) , Ltd.. It received FDA 510(k) clearance on 2000-05-17 under 510(k) number K000775. 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 HEART 2005?

HEART 2005 is a medical device that received FDA 510(k) clearance on 2000-05-17. The listed applicant is Aerotel Medical Systems (1998) , Ltd.. The 510(k) number is K000775.

When did HEART 2005 receive FDA 510(k) clearance?

HEART 2005 received FDA 510(k) clearance on 2000-05-17, under 510(k) number K000775.

Who is the listed applicant for HEART 2005?

The FDA 510(k) record lists Aerotel Medical Systems (1998) , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEART 2005?

The FDA product code for HEART 2005 is DXH. This falls under the Hematology category.

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Other records listing Aerotel Medical Systems (1998) , Ltd. 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.

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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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