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FDA 510(k)

TRANSMITTER & RECEIVERS, TELEPHONE, ELEC

K-Number: K810608 · 1981-05-01

ApplicantHeart Check Systems, Inc.
Decision Date1981-05-01
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRANSMITTER & RECEIVERS, TELEPHONE, ELEC is the device name listed in this FDA 510(k) record. The listed applicant is Heart Check Systems, Inc.. It received FDA 510(k) clearance on 1981-05-01 under 510(k) number K810608. 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 TRANSMITTER & RECEIVERS, TELEPHONE, ELEC?

TRANSMITTER & RECEIVERS, TELEPHONE, ELEC is a medical device that received FDA 510(k) clearance on 1981-05-01. The listed applicant is Heart Check Systems, Inc.. The 510(k) number is K810608.

When did TRANSMITTER & RECEIVERS, TELEPHONE, ELEC receive FDA 510(k) clearance?

TRANSMITTER & RECEIVERS, TELEPHONE, ELEC received FDA 510(k) clearance on 1981-05-01, under 510(k) number K810608.

Who is the listed applicant for TRANSMITTER & RECEIVERS, TELEPHONE, ELEC?

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

What is the FDA product code for TRANSMITTER & RECEIVERS, TELEPHONE, ELEC?

The FDA product code for TRANSMITTER & RECEIVERS, TELEPHONE, ELEC is DXH. This falls under the Hematology category.

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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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