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FDA 510(k)

MXT-2 12 LEAD MICRO-TRANSMITTER

K-Number: K933012 · 1994-03-14

ApplicantMedical Electronic Record Exchange
Decision Date1994-03-14
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MXT-2 12 LEAD MICRO-TRANSMITTER is the device name listed in this FDA 510(k) record. The listed applicant is Medical Electronic Record Exchange. It received FDA 510(k) clearance on 1994-03-14 under 510(k) number K933012. 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 MXT-2 12 LEAD MICRO-TRANSMITTER?

MXT-2 12 LEAD MICRO-TRANSMITTER is a medical device that received FDA 510(k) clearance on 1994-03-14. The listed applicant is Medical Electronic Record Exchange. The 510(k) number is K933012.

When did MXT-2 12 LEAD MICRO-TRANSMITTER receive FDA 510(k) clearance?

MXT-2 12 LEAD MICRO-TRANSMITTER received FDA 510(k) clearance on 1994-03-14, under 510(k) number K933012.

Who is the listed applicant for MXT-2 12 LEAD MICRO-TRANSMITTER?

The FDA 510(k) record lists Medical Electronic Record Exchange as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MXT-2 12 LEAD MICRO-TRANSMITTER?

The FDA product code for MXT-2 12 LEAD MICRO-TRANSMITTER is DXH. This falls under the Hematology category.

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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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