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FDA 510(k)

AIR TECHNIQUES' AIRDENT II

K-Number: K981564 · 1998-09-24

ApplicantAir Techniques, Inc.
Decision Date1998-09-24
Product CodeKOJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AIR TECHNIQUES' AIRDENT II is the device name listed in this FDA 510(k) record. The listed applicant is Air Techniques, Inc.. It received FDA 510(k) clearance on 1998-09-24 under 510(k) number K981564. 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 AIR TECHNIQUES' AIRDENT II?

AIR TECHNIQUES' AIRDENT II is a medical device that received FDA 510(k) clearance on 1998-09-24. The listed applicant is Air Techniques, Inc.. The 510(k) number is K981564.

When did AIR TECHNIQUES' AIRDENT II receive FDA 510(k) clearance?

AIR TECHNIQUES' AIRDENT II received FDA 510(k) clearance on 1998-09-24, under 510(k) number K981564.

Who is the listed applicant for AIR TECHNIQUES' AIRDENT II?

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

What is the FDA product code for AIR TECHNIQUES' AIRDENT II?

The FDA product code for AIR TECHNIQUES' AIRDENT II is KOJ.

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Other records listing Air Techniques, Inc. as applicant

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Related Devices (Code: KOJ)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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