FDA 510(k)

16ch Tx/Rx Knee SPEEDER

K-Number: K161193 · 2016-06-02

Decision Date2016-06-02

Product CodeMOS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

16ch Tx/Rx Knee SPEEDER is a medical device manufactured by Quality Electrodynamics, LLC. It received FDA 510(k) clearance on 2016-06-02 under approval number K161193. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 16ch Tx/Rx Knee SPEEDER?

16ch Tx/Rx Knee SPEEDER is a medical device that received FDA 510(k) clearance on 2016-06-02. It is manufactured by Quality Electrodynamics, LLC. The 510(k) number is K161193.

When was 16ch Tx/Rx Knee SPEEDER approved by the FDA?

16ch Tx/Rx Knee SPEEDER received FDA 510(k) clearance on 2016-06-02, under approval number K161193.

What company makes 16ch Tx/Rx Knee SPEEDER?

16ch Tx/Rx Knee SPEEDER is manufactured by Quality Electrodynamics, LLC.

What is the FDA product code for 16ch Tx/Rx Knee SPEEDER?

The FDA product code for 16ch Tx/Rx Knee SPEEDER is MOS.

Other Devices by Quality Electrodynamics, LLC

K16262316ch T/R Hand Wrist Coil K162966TxRx Knee 15 Flare MR Coil 1.5T K163066TxRx Knee 15 Flare MR Coil 3.0T K16202916ch T/R Knee Coil K173446Contour 24 K1629468ch Knee-Foot SPEEDER

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Related Devices (Code: MOS)

K16262316ch T/R Hand Wrist CoilQuality Electrodynamics, LLC K162966TxRx Knee 15 Flare MR Coil 1.5TQuality Electrodynamics, LLC K163066TxRx Knee 15 Flare MR Coil 3.0TQuality Electrodynamics, LLC K162863dS Small Extremity 16CH 1.5T CoilInvivo Therapeutics Corporation K16202916ch T/R Knee CoilQuality Electrodynamics, LLC K162079TRILLIUM Oval Head Coil 32Hitachi Medical Systems America, Inc.

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.