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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 the device name listed in this FDA 510(k) record. The listed applicant is Rolence Enterprise, Inc.. It received FDA 510(k) clearance on 2021-09-15 under 510(k) 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. The listed applicant is Rolence Enterprise, Inc.. The 510(k) number is K202369.

When did RXS 1000 receive FDA 510(k) clearance?

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

Who is the listed applicant for RXS 1000?

The FDA 510(k) record lists Rolence Enterprise, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RXS 1000?

The FDA product code for RXS 1000 is MUH.

Other records listing Rolence Enterprise, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K172928Portable X-ray System

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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