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FDA 510(k)

GYNESONICS EC6 TRANSDUCER

K-Number: K061153 · 2006-10-27

ApplicantGynesonics, Inc.
Decision Date2006-10-27
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GYNESONICS EC6 TRANSDUCER is the device name listed in this FDA 510(k) record. The listed applicant is Gynesonics, Inc.. It received FDA 510(k) clearance on 2006-10-27 under 510(k) number K061153. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GYNESONICS EC6 TRANSDUCER?

GYNESONICS EC6 TRANSDUCER is a medical device that received FDA 510(k) clearance on 2006-10-27. The listed applicant is Gynesonics, Inc.. The 510(k) number is K061153.

When did GYNESONICS EC6 TRANSDUCER receive FDA 510(k) clearance?

GYNESONICS EC6 TRANSDUCER received FDA 510(k) clearance on 2006-10-27, under 510(k) number K061153.

Who is the listed applicant for GYNESONICS EC6 TRANSDUCER?

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

What is the FDA product code for GYNESONICS EC6 TRANSDUCER?

The FDA product code for GYNESONICS EC6 TRANSDUCER is ITX.

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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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