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FDA 510(k)

CLEARREAD +CONFIRM

K-Number: K123526 · 2012-12-27

ApplicantRiverain Technologies
Decision Date2012-12-27
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CLEARREAD +CONFIRM is the device name listed in this FDA 510(k) record. The listed applicant is Riverain Technologies. It received FDA 510(k) clearance on 2012-12-27 under 510(k) number K123526. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEARREAD +CONFIRM?

CLEARREAD +CONFIRM is a medical device that received FDA 510(k) clearance on 2012-12-27. The listed applicant is Riverain Technologies. The 510(k) number is K123526.

When did CLEARREAD +CONFIRM receive FDA 510(k) clearance?

CLEARREAD +CONFIRM received FDA 510(k) clearance on 2012-12-27, under 510(k) number K123526.

Who is the listed applicant for CLEARREAD +CONFIRM?

The FDA 510(k) record lists Riverain Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLEARREAD +CONFIRM?

The FDA product code for CLEARREAD +CONFIRM is LLZ.

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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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