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FDA 510(k)

OMNI-DL SYSTEM

K-Number: K080650 · 2008-11-26

ApplicantTransvivo, Inc.
Decision Date2008-11-26
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OMNI-DL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Transvivo, Inc.. It received FDA 510(k) clearance on 2008-11-26 under 510(k) number K080650. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNI-DL SYSTEM?

OMNI-DL SYSTEM is a medical device that received FDA 510(k) clearance on 2008-11-26. The listed applicant is Transvivo, Inc.. The 510(k) number is K080650.

When did OMNI-DL SYSTEM receive FDA 510(k) clearance?

OMNI-DL SYSTEM received FDA 510(k) clearance on 2008-11-26, under 510(k) number K080650.

Who is the listed applicant for OMNI-DL SYSTEM?

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

What is the FDA product code for OMNI-DL SYSTEM?

The FDA product code for OMNI-DL SYSTEM is KDI.

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Related Devices (Code: KDI)

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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