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FDA 510(k)

TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER

K-Number: K934975 · 1995-04-06

ApplicantRlt Medical Assoc., Inc.
Decision Date1995-04-06
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER is the device name listed in this FDA 510(k) record. The listed applicant is Rlt Medical Assoc., Inc.. It received FDA 510(k) clearance on 1995-04-06 under 510(k) number K934975. 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 TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER?

TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER is a medical device that received FDA 510(k) clearance on 1995-04-06. The listed applicant is Rlt Medical Assoc., Inc.. The 510(k) number is K934975.

When did TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER receive FDA 510(k) clearance?

TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER received FDA 510(k) clearance on 1995-04-06, under 510(k) number K934975.

Who is the listed applicant for TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER?

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

What is the FDA product code for TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER?

The FDA product code for TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER is DXH. This falls under the Hematology category.

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Other records listing Rlt Medical Assoc., 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.

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Official Source

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