Air Techniques' Airdent II
FDA 510(k) K981564 · Air Techniques, Inc.
510(k) numberK981564
Submission
- Device name
- Air Techniques' Airdent II
- Applicant
- Air Techniques, Inc.
Hicksville, NY, US - Received
- May 1, 1998
- Decision date
- September 24, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Air Techniques' Airdent II cleared by the FDA?
Air Techniques' Airdent II (K981564) received a 510(k) decision of Substantially Equivalent on September 24, 1998, 146 days after the submission was received.
What is the product code of K981564?
The FDA product code is KOJ – Airbrush, a Class II (moderate risk) device regulated under 21 CFR 872.6080.