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FDA 510(k)

E-FAX REMOTE MONITOR

K-Number: K932863 · 1994-03-16

ApplicantCoherent Systems, Inc.
Decision Date1994-03-16
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

E-FAX REMOTE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Coherent Systems, Inc.. It received FDA 510(k) clearance on 1994-03-16 under 510(k) number K932863. 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 E-FAX REMOTE MONITOR?

E-FAX REMOTE MONITOR is a medical device that received FDA 510(k) clearance on 1994-03-16. The listed applicant is Coherent Systems, Inc.. The 510(k) number is K932863.

When did E-FAX REMOTE MONITOR receive FDA 510(k) clearance?

E-FAX REMOTE MONITOR received FDA 510(k) clearance on 1994-03-16, under 510(k) number K932863.

Who is the listed applicant for E-FAX REMOTE MONITOR?

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

What is the FDA product code for E-FAX REMOTE MONITOR?

The FDA product code for E-FAX REMOTE MONITOR is DXH. This falls under the Hematology category.

Related Clinical Trials

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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Other records listing Coherent Systems, 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.

K932859E-FAX RECEIVERK883152EP-STAT

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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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