Compuspeak

FDA 510(k) K941566 · Hogan & Hartson

Substantially Equivalent

510(k) numberK941566

Submission

Device name
Compuspeak
Applicant
Hogan & Hartson
Washington, DC, US
Received
April 1, 1994
Decision date
June 30, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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Questions and answers

When was Compuspeak cleared by the FDA?

Compuspeak (K941566) received a 510(k) decision of Substantially Equivalent on June 30, 1995, 455 days after the submission was received.

What is the product code of K941566?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.