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FDA 510(k)

TRANSTELEPHONIC ECG RECORDER/TRANSMITTER & RECEIVE

K-Number: K854013 · 1986-02-28

ApplicantMedrand, Inc.
Decision Date1986-02-28
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRANSTELEPHONIC ECG RECORDER/TRANSMITTER & RECEIVE is the device name listed in this FDA 510(k) record. The listed applicant is Medrand, Inc.. It received FDA 510(k) clearance on 1986-02-28 under 510(k) number K854013. 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 TRANSTELEPHONIC ECG RECORDER/TRANSMITTER & RECEIVE?

TRANSTELEPHONIC ECG RECORDER/TRANSMITTER & RECEIVE is a medical device that received FDA 510(k) clearance on 1986-02-28. The listed applicant is Medrand, Inc.. The 510(k) number is K854013.

When did TRANSTELEPHONIC ECG RECORDER/TRANSMITTER & RECEIVE receive FDA 510(k) clearance?

TRANSTELEPHONIC ECG RECORDER/TRANSMITTER & RECEIVE received FDA 510(k) clearance on 1986-02-28, under 510(k) number K854013.

Who is the listed applicant for TRANSTELEPHONIC ECG RECORDER/TRANSMITTER & RECEIVE?

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

What is the FDA product code for TRANSTELEPHONIC ECG RECORDER/TRANSMITTER & RECEIVE?

The FDA product code for TRANSTELEPHONIC ECG RECORDER/TRANSMITTER & RECEIVE is DXH. This falls under the Hematology category.

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Related Devices (Code: DXH)

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.

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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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