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FDA 510(k)

FUSION SYSTEM

K-Number: K093465 · 2010-01-05

ApplicantEclipsemed Global, Inc.
Decision Date2010-01-05
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Eclipsemed Global, Inc.. It received FDA 510(k) clearance on 2010-01-05 under 510(k) number K093465. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUSION SYSTEM?

FUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2010-01-05. The listed applicant is Eclipsemed Global, Inc.. The 510(k) number is K093465.

When did FUSION SYSTEM receive FDA 510(k) clearance?

FUSION SYSTEM received FDA 510(k) clearance on 2010-01-05, under 510(k) number K093465.

Who is the listed applicant for FUSION SYSTEM?

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

What is the FDA product code for FUSION SYSTEM?

The FDA product code for FUSION SYSTEM is ONF.

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 Eclipsemed Global, 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.

K100487EQUINOX CO2 LASER SYSTEM

Related Devices (Code: ONF)

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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