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FDA 510(k)

SAPHENEIA CLARITY

K-Number: K063391 · 2007-04-26

ApplicantSapheneia Commercial Products AB
Decision Date2007-04-26
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SAPHENEIA CLARITY is the device name listed in this FDA 510(k) record. The listed applicant is Sapheneia Commercial Products AB. It received FDA 510(k) clearance on 2007-04-26 under 510(k) number K063391. 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 SAPHENEIA CLARITY?

SAPHENEIA CLARITY is a medical device that received FDA 510(k) clearance on 2007-04-26. The listed applicant is Sapheneia Commercial Products AB. The 510(k) number is K063391.

When did SAPHENEIA CLARITY receive FDA 510(k) clearance?

SAPHENEIA CLARITY received FDA 510(k) clearance on 2007-04-26, under 510(k) number K063391.

Who is the listed applicant for SAPHENEIA CLARITY?

The FDA 510(k) record lists Sapheneia Commercial Products AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAPHENEIA CLARITY?

The FDA product code for SAPHENEIA CLARITY 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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