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FDA 510(k)

LIFE-TEL CELLULAR TRANSCEIVER

K-Number: K900541 · 1990-07-13

ApplicantRacom, Inc.
Decision Date1990-07-13
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LIFE-TEL CELLULAR TRANSCEIVER is the device name listed in this FDA 510(k) record. The listed applicant is Racom, Inc.. It received FDA 510(k) clearance on 1990-07-13 under 510(k) number K900541. 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 LIFE-TEL CELLULAR TRANSCEIVER?

LIFE-TEL CELLULAR TRANSCEIVER is a medical device that received FDA 510(k) clearance on 1990-07-13. The listed applicant is Racom, Inc.. The 510(k) number is K900541.

When did LIFE-TEL CELLULAR TRANSCEIVER receive FDA 510(k) clearance?

LIFE-TEL CELLULAR TRANSCEIVER received FDA 510(k) clearance on 1990-07-13, under 510(k) number K900541.

Who is the listed applicant for LIFE-TEL CELLULAR TRANSCEIVER?

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

What is the FDA product code for LIFE-TEL CELLULAR TRANSCEIVER?

The FDA product code for LIFE-TEL CELLULAR TRANSCEIVER is DXH. This falls under the Hematology category.

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Other records listing Racom, Inc. as applicant

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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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