FDA 510(k)

SONIXGPS

K-Number: K121812 · 2013-12-02

Decision Date2013-12-02

Product CodeBSP

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

SONIXGPS 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 2013-12-02 under 510(k) number K121812. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONIXGPS?

SONIXGPS is a medical device that received FDA 510(k) clearance on 2013-12-02. The listed applicant is Ultrasonix Medical Corporation. The 510(k) number is K121812.

When did SONIXGPS receive FDA 510(k) clearance?

SONIXGPS received FDA 510(k) clearance on 2013-12-02, under 510(k) number K121812.

Who is the listed applicant for SONIXGPS?

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?

The FDA product code for SONIXGPS is BSP.

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Other records listing Ultrasonix Medical Corporation as applicant

K111818SONIXGPS NEEDLE SENSOR K113663SONIXTABLET ULTRASOUND SCANNER K112726SONIX ULTRASOUND SCANNER K102997SONIXTABLET ULTRASOUND SCANNER K093462SONIX ULTRASOUND SCANNER K083095SONIXTOUCH ULTRASOUND SYSTEM

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Related Devices (Code: BSP)

K243690SonoMSKPAJUNK GmbH Medizintechnologie K243682SonoPlex STIM; SonoPlex IIPAJUNK GmbH Medizintechnologie K250774SPROTTE® STANDARD (LUER/ NRFit®) Lumbar PuncturePAJUNK GmbH Medizintechnologie K243525SonoTAP and SonoTAP IIPAJUNK GmbH Medizintechnologie K241953SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyPAJUNK GmbH Medizintechnologie K241954SonoBlock; SonoBlock IIPAJUNK GmbH Medizintechnologie

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.