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FDA 510(k)

CORFAX CARDIAC DATA TRANSMITTER

K-Number: K931585 · 1994-03-07

ApplicantRalin Medical, Inc.
Decision Date1994-03-07
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CORFAX CARDIAC DATA TRANSMITTER is the device name listed in this FDA 510(k) record. The listed applicant is Ralin Medical, Inc.. It received FDA 510(k) clearance on 1994-03-07 under 510(k) number K931585. 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 CORFAX CARDIAC DATA TRANSMITTER?

CORFAX CARDIAC DATA TRANSMITTER is a medical device that received FDA 510(k) clearance on 1994-03-07. The listed applicant is Ralin Medical, Inc.. The 510(k) number is K931585.

When did CORFAX CARDIAC DATA TRANSMITTER receive FDA 510(k) clearance?

CORFAX CARDIAC DATA TRANSMITTER received FDA 510(k) clearance on 1994-03-07, under 510(k) number K931585.

Who is the listed applicant for CORFAX CARDIAC DATA TRANSMITTER?

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

What is the FDA product code for CORFAX CARDIAC DATA TRANSMITTER?

The FDA product code for CORFAX CARDIAC DATA TRANSMITTER is DXH. This falls under the Hematology category.

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Other records listing Ralin Medical, 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.

K930888WRISTRECORDER PLUS CARDIAC EVENT RECORDING SYSTEM

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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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