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FDA 510(k)

PAGE-WRITER INTERPRETIVE CARDIOGRAPH

K-Number: K842370 · 1984-12-07

ApplicantHewlett-Packard Co.
Decision Date1984-12-07
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PAGE-WRITER INTERPRETIVE CARDIOGRAPH 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 1984-12-07 under 510(k) number K842370. 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 PAGE-WRITER INTERPRETIVE CARDIOGRAPH?

PAGE-WRITER INTERPRETIVE CARDIOGRAPH is a medical device that received FDA 510(k) clearance on 1984-12-07. The listed applicant is Hewlett-Packard Co.. The 510(k) number is K842370.

When did PAGE-WRITER INTERPRETIVE CARDIOGRAPH receive FDA 510(k) clearance?

PAGE-WRITER INTERPRETIVE CARDIOGRAPH received FDA 510(k) clearance on 1984-12-07, under 510(k) number K842370.

Who is the listed applicant for PAGE-WRITER INTERPRETIVE CARDIOGRAPH?

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 PAGE-WRITER INTERPRETIVE CARDIOGRAPH?

The FDA product code for PAGE-WRITER INTERPRETIVE CARDIOGRAPH is DXH. This falls under the Hematology category.

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Other records listing Hewlett-Packard Co. as applicant

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Related Devices (Code: DXH)

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.

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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.

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