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FDA 510(k)

MONITOR, MODEL 2817

K-Number: K902334 · 1990-06-26

ApplicantEsaote Biomedica Spa
Decision Date1990-06-26
Product CodeDXJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MONITOR, MODEL 2817 is the device name listed in this FDA 510(k) record. The listed applicant is Esaote Biomedica Spa. It received FDA 510(k) clearance on 1990-06-26 under 510(k) number K902334. The device is classified under product code DXJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONITOR, MODEL 2817?

MONITOR, MODEL 2817 is a medical device that received FDA 510(k) clearance on 1990-06-26. The listed applicant is Esaote Biomedica Spa. The 510(k) number is K902334.

When did MONITOR, MODEL 2817 receive FDA 510(k) clearance?

MONITOR, MODEL 2817 received FDA 510(k) clearance on 1990-06-26, under 510(k) number K902334.

Who is the listed applicant for MONITOR, MODEL 2817?

The FDA 510(k) record lists Esaote Biomedica Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MONITOR, MODEL 2817?

The FDA product code for MONITOR, MODEL 2817 is DXJ.

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Other records listing Esaote Biomedica Spa 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.

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Related Devices (Code: DXJ)

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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