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FDA 510(k)

HEARTRAK XL

K-Number: K960499 · 1996-08-06

ApplicantUniversal Medical, Inc.
Decision Date1996-08-06
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEARTRAK XL is the device name listed in this FDA 510(k) record. The listed applicant is Universal Medical, Inc.. It received FDA 510(k) clearance on 1996-08-06 under 510(k) number K960499. 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 HEARTRAK XL?

HEARTRAK XL is a medical device that received FDA 510(k) clearance on 1996-08-06. The listed applicant is Universal Medical, Inc.. The 510(k) number is K960499.

When did HEARTRAK XL receive FDA 510(k) clearance?

HEARTRAK XL received FDA 510(k) clearance on 1996-08-06, under 510(k) number K960499.

Who is the listed applicant for HEARTRAK XL?

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

What is the FDA product code for HEARTRAK XL?

The FDA product code for HEARTRAK XL is DXH. This falls under the Hematology category.

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Other records listing Universal Medical, 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.

K083535HEARTRAK SMART ECATK071130HEARTRAK AFK033451HEARTRAK SMART AT/HEARTRAK SMART2K980624CARDIOSTATIONK954495PACETRAK PLUSK943123PACETRAK

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Related Devices (Code: DXH)

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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