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FDA 510(k)

QUIESCENCE

K-Number: K040330 · 2004-04-12

ApplicantSpectral Visualization & Development, Inc.
Decision Date2004-04-12
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

QUIESCENCE is the device name listed in this FDA 510(k) record. The listed applicant is Spectral Visualization & Development, Inc.. It received FDA 510(k) clearance on 2004-04-12 under 510(k) number K040330. The device is classified under product code KLW. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUIESCENCE?

QUIESCENCE is a medical device that received FDA 510(k) clearance on 2004-04-12. The listed applicant is Spectral Visualization & Development, Inc.. The 510(k) number is K040330.

When did QUIESCENCE receive FDA 510(k) clearance?

QUIESCENCE received FDA 510(k) clearance on 2004-04-12, under 510(k) number K040330.

Who is the listed applicant for QUIESCENCE?

The FDA 510(k) record lists Spectral Visualization & Development, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUIESCENCE?

The FDA product code for QUIESCENCE is KLW.

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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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