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FDA 510(k)

AIRDENT II CS

K-Number: K001313 · 2000-06-08

ApplicantAir Technologies, Inc.
Decision Date2000-06-08
Product CodeKOJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AIRDENT II CS is the device name listed in this FDA 510(k) record. The listed applicant is Air Technologies, Inc.. It received FDA 510(k) clearance on 2000-06-08 under 510(k) number K001313. The device is classified under product code KOJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIRDENT II CS?

AIRDENT II CS is a medical device that received FDA 510(k) clearance on 2000-06-08. The listed applicant is Air Technologies, Inc.. The 510(k) number is K001313.

When did AIRDENT II CS receive FDA 510(k) clearance?

AIRDENT II CS received FDA 510(k) clearance on 2000-06-08, under 510(k) number K001313.

Who is the listed applicant for AIRDENT II CS?

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

What is the FDA product code for AIRDENT II CS?

The FDA product code for AIRDENT II CS is KOJ.

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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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