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FDA 510(k)

RXS 1000

K-Number: K202369 · 2021-09-15

ApplicantRolence Enterprise, Inc.
Decision Date2021-09-15
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RXS 1000 is a medical device manufactured by Rolence Enterprise, Inc.. It received FDA 510(k) clearance on 2021-09-15 under approval number K202369. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RXS 1000?

RXS 1000 is a medical device that received FDA 510(k) clearance on 2021-09-15. It is manufactured by Rolence Enterprise, Inc.. The 510(k) number is K202369.

When was RXS 1000 approved by the FDA?

RXS 1000 received FDA 510(k) clearance on 2021-09-15, under approval number K202369.

What company makes RXS 1000?

RXS 1000 is manufactured by Rolence Enterprise, Inc..

What is the FDA product code for RXS 1000?

The FDA product code for RXS 1000 is MUH.

Other Devices by Rolence Enterprise, Inc.

K172928Portable X-ray System

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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.

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