FDA 510(k)

MODIFIED MEMORYTRACE ER MODEL 4221 ECG MONITOR

K-Number: K915769 · 1992-01-30

Decision Date1992-01-30

Product CodeDXH

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MODIFIED MEMORYTRACE ER MODEL 4221 ECG MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1992-01-30 under 510(k) number K915769. 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 MODIFIED MEMORYTRACE ER MODEL 4221 ECG MONITOR?

MODIFIED MEMORYTRACE ER MODEL 4221 ECG MONITOR is a medical device that received FDA 510(k) clearance on 1992-01-30. The listed applicant is Medtronic Vascular. The 510(k) number is K915769.

When did MODIFIED MEMORYTRACE ER MODEL 4221 ECG MONITOR receive FDA 510(k) clearance?

MODIFIED MEMORYTRACE ER MODEL 4221 ECG MONITOR received FDA 510(k) clearance on 1992-01-30, under 510(k) number K915769.

Who is the listed applicant for MODIFIED MEMORYTRACE ER MODEL 4221 ECG MONITOR?

The FDA 510(k) record lists Medtronic Vascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFIED MEMORYTRACE ER MODEL 4221 ECG MONITOR?

The FDA product code for MODIFIED MEMORYTRACE ER MODEL 4221 ECG MONITOR 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.