Macom

FDA 510(k) K973148 · A.Stein - Regulatory Affairs Consulting

Substantially Equivalent

510(k) numberK973148

Submission

Device name
Macom
Applicant
A.Stein - Regulatory Affairs Consulting
Ginot Shomron 44853, IL
Received
August 22, 1997
Decision date
November 20, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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 Macom cleared by the FDA?

Macom (K973148) received a 510(k) decision of Substantially Equivalent on November 20, 1997, 90 days after the submission was received.

What is the product code of K973148?

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