Specboard

FDA 510(k) K891090 · Macbrud Corp. Medical Div.

Substantially Equivalent

510(k) numberK891090

Submission

Device name
Specboard
Applicant
Macbrud Corp. Medical Div.
Miami, FL, US
Received
March 6, 1989
Decision date
April 7, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IZH – System, X-Ray, Mammographic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1710
Specialty
Radiology

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More from Giotto USA, LLC

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K913049Slip-Pruf-ClingerKDD · Traditional 09/11/1991SE
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Questions and answers

When was Specboard cleared by the FDA?

Specboard (K891090) received a 510(k) decision of Substantially Equivalent on April 7, 1989, 32 days after the submission was received.

What is the product code of K891090?

The FDA product code is IZH – System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1710.