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FDA 510(k)

MODEM ACCESSORY FOR EPI CARDIA SYS

K-Number: K834034 · 1984-05-09

ApplicantMedicomp, Inc.
Decision Date1984-05-09
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEM ACCESSORY FOR EPI CARDIA SYS is the device name listed in this FDA 510(k) record. The listed applicant is Medicomp, Inc.. It received FDA 510(k) clearance on 1984-05-09 under 510(k) number K834034. 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 MODEM ACCESSORY FOR EPI CARDIA SYS?

MODEM ACCESSORY FOR EPI CARDIA SYS is a medical device that received FDA 510(k) clearance on 1984-05-09. The listed applicant is Medicomp, Inc.. The 510(k) number is K834034.

When did MODEM ACCESSORY FOR EPI CARDIA SYS receive FDA 510(k) clearance?

MODEM ACCESSORY FOR EPI CARDIA SYS received FDA 510(k) clearance on 1984-05-09, under 510(k) number K834034.

Who is the listed applicant for MODEM ACCESSORY FOR EPI CARDIA SYS?

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

What is the FDA product code for MODEM ACCESSORY FOR EPI CARDIA SYS?

The FDA product code for MODEM ACCESSORY FOR EPI CARDIA SYS 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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