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FDA 510(k)

DATAMED MODEL 401A TRANSRECIEVER

K-Number: K904966 · 1991-07-18

ApplicantDatamed, Inc.
Decision Date1991-07-18
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DATAMED MODEL 401A TRANSRECIEVER is the device name listed in this FDA 510(k) record. The listed applicant is Datamed, Inc.. It received FDA 510(k) clearance on 1991-07-18 under 510(k) number K904966. 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 DATAMED MODEL 401A TRANSRECIEVER?

DATAMED MODEL 401A TRANSRECIEVER is a medical device that received FDA 510(k) clearance on 1991-07-18. The listed applicant is Datamed, Inc.. The 510(k) number is K904966.

When did DATAMED MODEL 401A TRANSRECIEVER receive FDA 510(k) clearance?

DATAMED MODEL 401A TRANSRECIEVER received FDA 510(k) clearance on 1991-07-18, under 510(k) number K904966.

Who is the listed applicant for DATAMED MODEL 401A TRANSRECIEVER?

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

What is the FDA product code for DATAMED MODEL 401A TRANSRECIEVER?

The FDA product code for DATAMED MODEL 401A TRANSRECIEVER is DXH. This falls under the Hematology category.

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Other records listing Datamed, 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.

K841858SPIROLOOPK811419SPRIO-LOOP

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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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