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FDA 510(k)

ORAMOIST

K-Number: K122663 · 2013-05-30

ApplicantQuantum, Inc.
Decision Date2013-05-30
Product CodeLFD
DecisionSubstantially Equivalent

Device Summary

ORAMOIST is the device name listed in this FDA 510(k) record. The listed applicant is Quantum, Inc.. It received FDA 510(k) clearance on 2013-05-30 under 510(k) number K122663. The device is classified under product code LFD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORAMOIST?

ORAMOIST is a medical device that received FDA 510(k) clearance on 2013-05-30. The listed applicant is Quantum, Inc.. The 510(k) number is K122663.

When did ORAMOIST receive FDA 510(k) clearance?

ORAMOIST received FDA 510(k) clearance on 2013-05-30, under 510(k) number K122663.

Who is the listed applicant for ORAMOIST?

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

What is the FDA product code for ORAMOIST?

The FDA product code for ORAMOIST is LFD.

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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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