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FDA 510(k)

DIO SM IMPLANT SYSTEM

K-Number: K080559 · 2008-10-09

ApplicantDsi, Inc.
Decision Date2008-10-09
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DIO SM IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dsi, Inc.. It received FDA 510(k) clearance on 2008-10-09 under 510(k) number K080559. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIO SM IMPLANT SYSTEM?

DIO SM IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2008-10-09. The listed applicant is Dsi, Inc.. The 510(k) number is K080559.

When did DIO SM IMPLANT SYSTEM receive FDA 510(k) clearance?

DIO SM IMPLANT SYSTEM received FDA 510(k) clearance on 2008-10-09, under 510(k) number K080559.

Who is the listed applicant for DIO SM IMPLANT SYSTEM?

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

What is the FDA product code for DIO SM IMPLANT SYSTEM?

The FDA product code for DIO SM IMPLANT SYSTEM is DZE.

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Related Devices (Code: DZE)

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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