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FDA 510(k)

MEMORYTRACE ATM MODEL 4222

K-Number: K941898 · 1995-06-26

ApplicantHi-Tronics Designs, Inc.
Decision Date1995-06-26
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEMORYTRACE ATM MODEL 4222 is the device name listed in this FDA 510(k) record. The listed applicant is Hi-Tronics Designs, Inc.. It received FDA 510(k) clearance on 1995-06-26 under 510(k) number K941898. 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 MEMORYTRACE ATM MODEL 4222?

MEMORYTRACE ATM MODEL 4222 is a medical device that received FDA 510(k) clearance on 1995-06-26. The listed applicant is Hi-Tronics Designs, Inc.. The 510(k) number is K941898.

When did MEMORYTRACE ATM MODEL 4222 receive FDA 510(k) clearance?

MEMORYTRACE ATM MODEL 4222 received FDA 510(k) clearance on 1995-06-26, under 510(k) number K941898.

Who is the listed applicant for MEMORYTRACE ATM MODEL 4222?

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

What is the FDA product code for MEMORYTRACE ATM MODEL 4222?

The FDA product code for MEMORYTRACE ATM MODEL 4222 is DXH. This falls under the Hematology category.

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Other records listing Hi-Tronics Designs, 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.

K973863MEMORYTRACE MODEL 4224 AMBULATORY ECG MONITOR

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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