A/T X-Ray 70

FDA 510(k) K024285 · Air Techniques, Inc.

Substantially Equivalent

510(k) numberK024285

Submission

Device name
A/T X-Ray 70
Applicant
Air Techniques, Inc.
Hicksville, NY, US
Received
December 23, 2002
Decision date
April 16, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
EHD – Unit, X-Ray, Extraoral With Timer
Device class
Class II (moderate risk)
Regulation
21 CFR 872.1800
Specialty
Dental

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Questions and answers

When was A/T X-Ray 70 cleared by the FDA?

A/T X-Ray 70 (K024285) received a 510(k) decision of Substantially Equivalent on April 16, 2003, 114 days after the submission was received.

What is the product code of K024285?

The FDA product code is EHD – Unit, X-Ray, Extraoral With Timer, a Class II (moderate risk) device regulated under 21 CFR 872.1800.