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FDA 510(k)

WELLSHIRE EMLINK MODEL 1000

K-Number: K890508 · 1989-03-02

ApplicantAmerican Executive Technology
Decision Date1989-03-02
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WELLSHIRE EMLINK MODEL 1000 is the device name listed in this FDA 510(k) record. The listed applicant is American Executive Technology. It received FDA 510(k) clearance on 1989-03-02 under 510(k) number K890508. 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 WELLSHIRE EMLINK MODEL 1000?

WELLSHIRE EMLINK MODEL 1000 is a medical device that received FDA 510(k) clearance on 1989-03-02. The listed applicant is American Executive Technology. The 510(k) number is K890508.

When did WELLSHIRE EMLINK MODEL 1000 receive FDA 510(k) clearance?

WELLSHIRE EMLINK MODEL 1000 received FDA 510(k) clearance on 1989-03-02, under 510(k) number K890508.

Who is the listed applicant for WELLSHIRE EMLINK MODEL 1000?

The FDA 510(k) record lists American Executive Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WELLSHIRE EMLINK MODEL 1000?

The FDA product code for WELLSHIRE EMLINK MODEL 1000 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 American Executive Technology 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.

K890558WELLSHIRE BASELINK

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

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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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