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FDA 510(k)

HEART AIDE MULTPLE/HEART AIDE PLUS/HEART AIDE PLUS II

K-Number: K964888 · 1997-02-28

ApplicantTz Medical, Inc.
Decision Date1997-02-28
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEART AIDE MULTPLE/HEART AIDE PLUS/HEART AIDE PLUS II is the device name listed in this FDA 510(k) record. The listed applicant is Tz Medical, Inc.. It received FDA 510(k) clearance on 1997-02-28 under 510(k) number K964888. 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 AIDE MULTPLE/HEART AIDE PLUS/HEART AIDE PLUS II?

HEART AIDE MULTPLE/HEART AIDE PLUS/HEART AIDE PLUS II is a medical device that received FDA 510(k) clearance on 1997-02-28. The listed applicant is Tz Medical, Inc.. The 510(k) number is K964888.

When did HEART AIDE MULTPLE/HEART AIDE PLUS/HEART AIDE PLUS II receive FDA 510(k) clearance?

HEART AIDE MULTPLE/HEART AIDE PLUS/HEART AIDE PLUS II received FDA 510(k) clearance on 1997-02-28, under 510(k) number K964888.

Who is the listed applicant for HEART AIDE MULTPLE/HEART AIDE PLUS/HEART AIDE PLUS II?

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

What is the FDA product code for HEART AIDE MULTPLE/HEART AIDE PLUS/HEART AIDE PLUS II?

The FDA product code for HEART AIDE MULTPLE/HEART AIDE PLUS/HEART AIDE PLUS II 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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