FDA 510(k)

M1400A TRANSMITTER,M1402 RECEIVER,M1401 MAINFRAME

K-Number: K894277 · 1989-09-26

Decision Date1989-09-26

Product CodeDXH

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

M1400A TRANSMITTER,M1402 RECEIVER,M1401 MAINFRAME is the device name listed in this FDA 510(k) record. The listed applicant is Hewlett-Packard Co.. It received FDA 510(k) clearance on 1989-09-26 under 510(k) number K894277. 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 M1400A TRANSMITTER,M1402 RECEIVER,M1401 MAINFRAME?

M1400A TRANSMITTER,M1402 RECEIVER,M1401 MAINFRAME is a medical device that received FDA 510(k) clearance on 1989-09-26. The listed applicant is Hewlett-Packard Co.. The 510(k) number is K894277.

When did M1400A TRANSMITTER,M1402 RECEIVER,M1401 MAINFRAME receive FDA 510(k) clearance?

M1400A TRANSMITTER,M1402 RECEIVER,M1401 MAINFRAME received FDA 510(k) clearance on 1989-09-26, under 510(k) number K894277.

Who is the listed applicant for M1400A TRANSMITTER,M1402 RECEIVER,M1401 MAINFRAME?

The FDA 510(k) record lists Hewlett-Packard Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for M1400A TRANSMITTER,M1402 RECEIVER,M1401 MAINFRAME?

The FDA product code for M1400A TRANSMITTER,M1402 RECEIVER,M1401 MAINFRAME is DXH. This falls under the Hematology category.

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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.