FDA 510(k)

8ch Flex Suite

K-Number: K172222 · 2017-12-08

Decision Date2017-12-08

Product CodeMOS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

8ch Flex Suite is a medical device manufactured by Shenzhen RF Tech Co., Ltd.. It received FDA 510(k) clearance on 2017-12-08 under approval number K172222. 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 8ch Flex Suite?

8ch Flex Suite is a medical device that received FDA 510(k) clearance on 2017-12-08. It is manufactured by Shenzhen RF Tech Co., Ltd.. The 510(k) number is K172222.

When was 8ch Flex Suite approved by the FDA?

8ch Flex Suite received FDA 510(k) clearance on 2017-12-08, under approval number K172222.

What company makes 8ch Flex Suite?

8ch Flex Suite is manufactured by Shenzhen RF Tech Co., Ltd..

What is the FDA product code for 8ch Flex Suite?

The FDA product code for 8ch Flex Suite is MOS.

Other Devices by Shenzhen RF Tech Co., Ltd.

K1609328ch Foot Ankle Coil K1609358ch Foot Ankle Coil K2008368ch Flex Suite K2232398ch Wrist Coil K2310851.5T HD T/R Knee Array (10-F34127) K2232031.5T 24E Posterior Array

View all 11 devices →

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.