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FDA 510(k)

TRANSPOSAL ULTRA SYSTEMS

K-Number: K081047 · 2008-04-29

ApplicantDornoch Medical Systems, Inc.
Decision Date2008-04-29
Product CodeJCX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TRANSPOSAL ULTRA SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Dornoch Medical Systems, Inc.. It received FDA 510(k) clearance on 2008-04-29 under 510(k) number K081047. The device is classified under product code JCX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANSPOSAL ULTRA SYSTEMS?

TRANSPOSAL ULTRA SYSTEMS is a medical device that received FDA 510(k) clearance on 2008-04-29. The listed applicant is Dornoch Medical Systems, Inc.. The 510(k) number is K081047.

When did TRANSPOSAL ULTRA SYSTEMS receive FDA 510(k) clearance?

TRANSPOSAL ULTRA SYSTEMS received FDA 510(k) clearance on 2008-04-29, under 510(k) number K081047.

Who is the listed applicant for TRANSPOSAL ULTRA SYSTEMS?

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

What is the FDA product code for TRANSPOSAL ULTRA SYSTEMS?

The FDA product code for TRANSPOSAL ULTRA SYSTEMS is JCX.

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Other records listing Dornoch Medical Systems, Inc. as applicant

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Related Devices (Code: JCX)

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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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