FDA 510(k)

SONIXGPS NEEDLE SENSOR

K-Number: K111818 · 2012-06-13

Decision Date2012-06-13

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SONIXGPS NEEDLE SENSOR is the device name listed in this FDA 510(k) record. The listed applicant is Ultrasonix Medical Corporation. It received FDA 510(k) clearance on 2012-06-13 under 510(k) number K111818. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONIXGPS NEEDLE SENSOR?

SONIXGPS NEEDLE SENSOR is a medical device that received FDA 510(k) clearance on 2012-06-13. The listed applicant is Ultrasonix Medical Corporation. The 510(k) number is K111818.

When did SONIXGPS NEEDLE SENSOR receive FDA 510(k) clearance?

SONIXGPS NEEDLE SENSOR received FDA 510(k) clearance on 2012-06-13, under 510(k) number K111818.

Who is the listed applicant for SONIXGPS NEEDLE SENSOR?

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

What is the FDA product code for SONIXGPS NEEDLE SENSOR?

The FDA product code for SONIXGPS NEEDLE SENSOR is IYO.

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Other records listing Ultrasonix Medical Corporation as applicant

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Related Devices (Code: IYO)

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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.