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FDA 510(k)

DIO STEADY EXTERNAL IMPLANT SYSTEM

K-Number: K100100 · 2010-11-10

ApplicantDio Corporation
Decision Date2010-11-10
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DIO STEADY EXTERNAL IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dio Corporation. It received FDA 510(k) clearance on 2010-11-10 under 510(k) number K100100. 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 STEADY EXTERNAL IMPLANT SYSTEM?

DIO STEADY EXTERNAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2010-11-10. The listed applicant is Dio Corporation. The 510(k) number is K100100.

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

DIO STEADY EXTERNAL IMPLANT SYSTEM received FDA 510(k) clearance on 2010-11-10, under 510(k) number K100100.

Who is the listed applicant for DIO STEADY EXTERNAL IMPLANT SYSTEM?

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

What is the FDA product code for DIO STEADY EXTERNAL IMPLANT SYSTEM?

The FDA product code for DIO STEADY EXTERNAL IMPLANT SYSTEM is DZE.

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Other records listing Dio Corporation as applicant

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Related Devices (Code: DZE)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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