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FDA 510(k)

SONICEYE ULTRASOUND TRANSDUCER

K-Number: K113832 · 2012-03-06

ApplicantBlacktoe Medical Iii, Inc.
Decision Date2012-03-06
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SONICEYE ULTRASOUND TRANSDUCER is the device name listed in this FDA 510(k) record. The listed applicant is Blacktoe Medical Iii, Inc.. It received FDA 510(k) clearance on 2012-03-06 under 510(k) number K113832. 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 SONICEYE ULTRASOUND TRANSDUCER?

SONICEYE ULTRASOUND TRANSDUCER is a medical device that received FDA 510(k) clearance on 2012-03-06. The listed applicant is Blacktoe Medical Iii, Inc.. The 510(k) number is K113832.

When did SONICEYE ULTRASOUND TRANSDUCER receive FDA 510(k) clearance?

SONICEYE ULTRASOUND TRANSDUCER received FDA 510(k) clearance on 2012-03-06, under 510(k) number K113832.

Who is the listed applicant for SONICEYE ULTRASOUND TRANSDUCER?

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

What is the FDA product code for SONICEYE ULTRASOUND TRANSDUCER?

The FDA product code for SONICEYE ULTRASOUND 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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