Pulse Klystron Amplifier (L-5822-00)

FDA 510(k) K951142 · Litton Systems, Inc.

Substantially Equivalent

510(k) numberK951142

Submission

Device name
Pulse Klystron Amplifier (L-5822-00)
Applicant
Litton Systems, Inc.
San Carlos, CA, US
Received
March 13, 1995
Decision date
June 16, 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
IYE – Accelerator, Linear, Medical
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5050
Specialty
Radiology

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Questions and answers

When was Pulse Klystron Amplifier (L-5822-00) cleared by the FDA?

Pulse Klystron Amplifier (L-5822-00) (K951142) received a 510(k) decision of Substantially Equivalent on June 16, 1995, 95 days after the submission was received.

What is the product code of K951142?

The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.