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FDA 510(k)

ELECTROCARDIOGRAPH TRANSMITTER, 536

K-Number: K772186 · 1978-02-02

ApplicantIntermedics, Inc.
Decision Date1978-02-02
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELECTROCARDIOGRAPH TRANSMITTER, 536 is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics, Inc.. It received FDA 510(k) clearance on 1978-02-02 under 510(k) number K772186. 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 ELECTROCARDIOGRAPH TRANSMITTER, 536?

ELECTROCARDIOGRAPH TRANSMITTER, 536 is a medical device that received FDA 510(k) clearance on 1978-02-02. The listed applicant is Intermedics, Inc.. The 510(k) number is K772186.

When did ELECTROCARDIOGRAPH TRANSMITTER, 536 receive FDA 510(k) clearance?

ELECTROCARDIOGRAPH TRANSMITTER, 536 received FDA 510(k) clearance on 1978-02-02, under 510(k) number K772186.

Who is the listed applicant for ELECTROCARDIOGRAPH TRANSMITTER, 536?

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

What is the FDA product code for ELECTROCARDIOGRAPH TRANSMITTER, 536?

The FDA product code for ELECTROCARDIOGRAPH TRANSMITTER, 536 is DXH. This falls under the Hematology category.

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Other records listing Intermedics, Inc. as applicant

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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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