FDA 510(k)

1.5T HD T/R Knee Array (10-F34127)

K-Number: K231085 · 2023-08-18

Decision Date2023-08-18

Product CodeMOS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

1.5T HD T/R Knee Array (10-F34127) is a medical device manufactured by Shenzhen RF Tech Co., Ltd.. It received FDA 510(k) clearance on 2023-08-18 under approval number K231085. 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 1.5T HD T/R Knee Array (10-F34127)?

1.5T HD T/R Knee Array (10-F34127) is a medical device that received FDA 510(k) clearance on 2023-08-18. It is manufactured by Shenzhen RF Tech Co., Ltd.. The 510(k) number is K231085.

When was 1.5T HD T/R Knee Array (10-F34127) approved by the FDA?

1.5T HD T/R Knee Array (10-F34127) received FDA 510(k) clearance on 2023-08-18, under approval number K231085.

What company makes 1.5T HD T/R Knee Array (10-F34127)?

1.5T HD T/R Knee Array (10-F34127) is manufactured by Shenzhen RF Tech Co., Ltd..

What is the FDA product code for 1.5T HD T/R Knee Array (10-F34127)?

The FDA product code for 1.5T HD T/R Knee Array (10-F34127) is MOS.

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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.