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FDA 510(k)

ROM PLUS

K-Number: K110605 · 2011-11-23

ApplicantClinical Innovations, LLC
Decision Date2011-11-23
Product CodeNQM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ROM PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Innovations, LLC. It received FDA 510(k) clearance on 2011-11-23 under 510(k) number K110605. The device is classified under product code NQM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROM PLUS?

ROM PLUS is a medical device that received FDA 510(k) clearance on 2011-11-23. The listed applicant is Clinical Innovations, LLC. The 510(k) number is K110605.

When did ROM PLUS receive FDA 510(k) clearance?

ROM PLUS received FDA 510(k) clearance on 2011-11-23, under 510(k) number K110605.

Who is the listed applicant for ROM PLUS?

The FDA 510(k) record lists Clinical Innovations, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROM PLUS?

The FDA product code for ROM PLUS is NQM.

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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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