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FDA 510(k)

PRINTER INTERFACE

K-Number: K970305 · 1997-08-15

ApplicantMicromedical, Inc.
Decision Date1997-08-15
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRINTER INTERFACE is the device name listed in this FDA 510(k) record. The listed applicant is Micromedical, Inc.. It received FDA 510(k) clearance on 1997-08-15 under 510(k) number K970305. 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 PRINTER INTERFACE?

PRINTER INTERFACE is a medical device that received FDA 510(k) clearance on 1997-08-15. The listed applicant is Micromedical, Inc.. The 510(k) number is K970305.

When did PRINTER INTERFACE receive FDA 510(k) clearance?

PRINTER INTERFACE received FDA 510(k) clearance on 1997-08-15, under 510(k) number K970305.

Who is the listed applicant for PRINTER INTERFACE?

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

What is the FDA product code for PRINTER INTERFACE?

The FDA product code for PRINTER INTERFACE is DXH. This falls under the Hematology category.

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Other records listing Micromedical, 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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