Eureka X-Scan 150 X-Ray Tube Housing As.

FDA 510(k) K760604 · Eureka X-Ray Tube Corp.

Substantially Equivalent

510(k) numberK760604

Submission

Device name
Eureka X-Scan 150 X-Ray Tube Housing As.
Applicant
Eureka X-Ray Tube Corp.
Mchenry, IL, US
Received
September 8, 1976
Decision date
September 13, 1976
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
ITY – Assembly, Tube Housing, X-Ray, Diagnostic
Device class
Class I (low risk)
Regulation
21 CFR 892.1760
Specialty
Radiology

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Questions and answers

When was Eureka X-Scan 150 X-Ray Tube Housing As. cleared by the FDA?

Eureka X-Scan 150 X-Ray Tube Housing As. (K760604) received a 510(k) decision of Substantially Equivalent on September 13, 1976, 5 days after the submission was received.

What is the product code of K760604?

The FDA product code is ITY – Assembly, Tube Housing, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1760.