Focus

FDA 510(k) K001729 · Instrumentarium Corp.

Substantially Equivalent

510(k) numberK001729

Submission

Device name
Focus
Applicant
Instrumentarium Corp.
Milwaukee, WI, US
Received
June 7, 2000
Decision date
July 13, 2000
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 Focus cleared by the FDA?

Focus (K001729) received a 510(k) decision of Substantially Equivalent on July 13, 2000, 36 days after the submission was received.

What is the product code of K001729?

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